Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001239752p
Ethics application status
Submitted, not yet approved
Date submitted
23/08/2022
Date registered
14/09/2022
Date last updated
14/09/2022
Date data sharing statement initially provided
14/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical First In Man study of the safety and performance of the Genesis Medtech Innovation Private Limited SureClose Vascular Closure Device (VCD) for Use in Closing Femoral Access Sites
Scientific title
Clinical First In Man study of the safety and performance of the Genesis Medtech Innovation Private Limited SureClose Vascular Closure Device (VCD) for Use in Closing Femoral Access Sites
Secondary ID [1] 307833 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular closure device for vascular disease requiring endovascular intervention thru arterial access 327438 0
Condition category
Condition code
Surgery 324561 324561 0 0
Other surgery
Cardiovascular 324717 324717 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Genesis Medtech Innovation SureClose Vascular Closure Device (VCD) is indicated for use for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures.

The SureClose VCD is a small mechanical device with a built-in needle and suture which can assist your doctor in closing the access site with a neat and repeatable knot and closure. This study will be the first time that the SureClose VCD will be tested in people. The study will help determine if the SureClose VCD can be used safely and successfully with positive outcomes for patient recovery and healing after their endovascular procedure.

Participants will be selected for participation in this research because they will be undergoing scheduled endovascular procedure of the type which will need to have the arterial access site closed. The research doctor will explain the main procedure and will perform the pre-procedure assessments and scheduled procedure and follow-up as per standard of care.
If participant agree to to take part in this study, the arterial puncture site will be closed using the experimental device at the end of the procedure. After the procedure participants will be will be closely followed-up for two to four weeks to check that your puncture site is healing as expected.

The study schedule is as follows:
• Screening
First Consultation:
Before any study-related procedures are done, the study doctor will explain the study and participants will have time to read the Participant Information and Consent Form and have the chance to ask any questions. Consent form will be signed if the participant decides to proceed. They will be given copy of the signed Participant Information and Consent Form to keep and the original copy will be put in your medical record. Your study doctor will also inform the participant’s local doctor (General Practitioner) that they participating in this research project. Participants should ask all other treating physicians to inform the study physician of any change in their medical condition, medications, including any emergency room visits and hospitalisations.

Second Consultation:
Participants have had time to consider their participation and after they have signed the consent form, the study doctor will ask you about and record your medical history and current medications to determine if they are eligible to participate in the study.
If they are eligible, they will have a physical examination, vital signs recording that includes blood pressure, heart rate, temperature and weight.

• Procedure
Participants will have their scheduled endovascular procedure as per standard of care. The procedures will be conducted at The Alfred Hospital surgical theatre, 55 Commercial Road, Melbourne 3004.

At the end of the endovascular procedure the catheter and any other devices used for your procedure will be removed from the artery as per standard process. The sterile, single-use SureClose would be inserted into the arterial puncture site and will be positioned appropriately. The research doctor may verify the location of the device by performing a quick ultrasound. This will cause no pain and can help ensure the safety of the procedure.

Once the SureClose is verified to be in place, the study doctor will deploy the suture needle which will automatically stitch and connect the two sides of the access site wound together. The suture is then knotted by the SureClose and an accessory tool will be used by the study doctor to push the knot down the suture to the degree of tension which the study doctor judges to be appropriate. The excess suture is trimmed away and the access site is closed quickly, neatly and with minimal blood loss.

The implantation of the CVD will take will take around 5-10 minutes.

Following the procedure, the study doctor will test the area to ensure proper suture tension and verify that the closure is complete.

Participants may notice bruising or tenderness in the area. This is normal and to be expected. There is no further action required unless any signs of unexpected bleeding or pain and tearing at the site. Signs of blood vessel damage should be reported to the study doctor immediately and will determine what additional steps are needed.

Following your doctor’s recommended visit plan for your endovascular procedure, they will also inspect the access site to ensure proper healing but no further action will be required on your part. The sutures do not need to be removed, so there will be no additional procedures required at the access site.

• Follow-Up at Discharge and at a hospital visit 2 to 4 weeks after the procedure
The access site will be assessed to check that it is healing as expected. The follow-up consultation is at 2 - 4 weeks will take about half an hour. Any adverse events will be recorded for the duration of the study.
Intervention code [1] 324299 0
Treatment: Devices
Intervention code [2] 324300 0
Treatment: Surgery
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332388 0
Safety endpoints at hospital discharge and at 14-30 day follow-up visits, trial participants will be monitored for the following:
• Femoral stenosis (> 50%) development at the puncture site related to closure technique. Mode of determination can be left to the clinician;
•Development of deep thrombosis in the target limb;
•Significant bleeding, retroperitoneal bleeding/hematoma, or hematoma at the access site requiring transfusion or surgical intervention;
•Hematoma that does not require transfusion or surgical intervention;
•Access site-related wound dehiscence or access site infection requiring intravenous, intramuscular or oral antibiotics, and/or leading to a prolonged hospitalization;
•Access site injury, including vessel laceration, requiring surgical repair, angioplasty, ultrasound-guided compression or thrombin injection;
•Re-bleeding at access site that requires treatment or re-hospitalization
Data will be collected through physical examinations and medical record for the above time points.
Timepoint [1] 332388 0
- Hospital discharge
- 14-30 day post- VCD implantation follow-up visits
Primary outcome [2] 332389 0
- Successful discharge of the device. Data will be collected from procedure report and medical record.
Timepoint [2] 332389 0
Immediately post-implant of VCD.
Primary outcome [3] 332438 0
Closure of the puncture. Securement of the suture knot and trimming of the suture ends. Data will be collected from procedure report and medical record.
Timepoint [3] 332438 0
Immediately post-implant of VCD
Secondary outcome [1] 413294 0
Ease of the System insert and locate within the patient. This will be documented using Procedure Form F004, specifically designed for this study.

Timepoint [1] 413294 0
During and immediately after VCD implantation
Secondary outcome [2] 413499 0
Completion of closure. Data will be collected from procedure report and medical record.
Timepoint [2] 413499 0
During and immediately after VCD implantation.

Eligibility
Key inclusion criteria
Inclusion Criteria - Patients must meet all of the following:
• Patient health is amenable to vascular closure;
• Are at least 18 years old at time of entry into the study;
• Signed informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria - Patients will be excluded should they meet any of the following:
• Patients with compromised immune systems or health conditions which would delay or otherwise extend healing past the proposed discharge timing of the study, i.e., 14-30 days post-procedure;
• Pregnant women;
• Patients with the access puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure;
• Patients who have experienced a recent (within 1 week) acute myocardial infarction or stroke;
• Pre-existing AV fistula;
• Pre-existing Pseudoaneurysm;
• Access site-related nerve injury;
• Clinical condition preventing patient from participating in the study;
• Contraindications to index procedure medications (heparin, aspirin, clopidogrel, and radiographic contrast).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The study will be a prospective nonrandomized single-arm trial of up to 12 patients, in total, enrolled at two centres. Appropriate patients will be enrolled into the study by the principal investigator at each site after obtaining informed consent. Patients will be evaluated with a clinical exam focusing on co-morbidities which would exclude them from enrolment; with visual examination at 14-30 days post-procedure, coincident with follow up for the indexed endovascular treatment post-procedure. Other examinations may be performed as deemed necessary by the investigator.

The stop criterion is: if 3 patients experience a device-related failure, related retreatment or hospitalization either at procedure or during the follow up period, then the study will be stopped.

As this is a safety and performance study, there will be no control group. The outcomes from the current study will be discussed in light of existing data on similar closure devices.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Twelve patients requiring femoral access after endovascular procedures.
The analyses of the data from this safety and feasibility study will be descriptive. The baseline demographic and prognostic factors will be summarized. For continuous variables, such as age, the mean, standard deviation, median, and range will be presented. For categorical variables such as gender, the proportion of patients in each category will be presented with 95% exact binomial confidence limits. For outcome variables, point estimates of the proportions and their 95% confidence limits will be analyzed and presented.

Management of dropouts and missing data will depend on their frequency and the nature of the outcome measure. All data will be included unless judged to be invalid.

The proportion of patients meeting the primary safety endpoint will be calculated. The proportion of patients experiencing any particular adverse event within the 14–30-day follow-up period will be tabulated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2022
Actual
Date of last participant enrolment
Anticipated
14/11/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23023 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 38340 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312107 0
Commercial sector/Industry
Name [1] 312107 0
Genesis Medtech Innovation Private Limited
Country [1] 312107 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
Genesis Medtech Innovation Private Limited
Address
16 Science Park Dr
DNV-GL Technology Centre, # 04-03
Singapore 118227
Country
Singapore
Secondary sponsor category [1] 313626 0
Commercial sector/Industry
Name [1] 313626 0
Pacific Clinical Research Group TM PTY Limited
Address [1] 313626 0
Level 36, 1 Macquarie Place Sydney, NSW 2000 Australia
Country [1] 313626 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311509 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 311509 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 311509 0
Australia
Date submitted for ethics approval [1] 311509 0
04/08/2022
Approval date [1] 311509 0
Ethics approval number [1] 311509 0

Summary
Brief summary
The objective of the proposed investigation is to assess the safety and performance of the Genesis Medtech Vascular Closure Device System used to close arterial access sites on patients undergoing endovascular interventions.

The study will be a prospective non-randomized, single-arm trial of up to 12 patients enrolled in two centres. Appropriate patients will be enrolled in the study by the principal investigator (PI) at each site after obtaining informed consent. Patients will have a basic health screening history recorded pre-operatively; with a clinical exam at hospital discharge; and with visual inspection of the closure site from 14-30 days, post-procedure; the timing of this last review is left open to the discretion of the PI and to best coincide with the scheduled follow up for the original endovascular procedure. Other examinations will be performed as deemed necessary by the investigator.

Safety will be evaluated by the incidence of adverse/serious adverse events at discharge (in clinic/hospital) and at the stated post-procedure follow-up intervals.

Performance will be measured in terms of technical evaluation of the device deployment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121350 0
Dr Thodur Vasudevan
Address 121350 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 121350 0
Australia
Phone 121350 0
+61 477775309
Fax 121350 0
Email 121350 0
t.vasudevan@alfred.org.au
Contact person for public queries
Name 121351 0
Dr Helen Kavnoudias
Address 121351 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 121351 0
Australia
Phone 121351 0
+61 413027175
Fax 121351 0
Email 121351 0
h.kavnoudias@alfred.org.au
Contact person for scientific queries
Name 121352 0
Dr Helen Kavnoudias
Address 121352 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 121352 0
Australia
Phone 121352 0
+61 413027175
Fax 121352 0
Email 121352 0
h.kavnoudias@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The outcome of this first in human trial will inform the sponsor on how to proceed with future studies. Future activities where study data may be used, would be for publications or for supplementing submissions to other notified bodies (e.g. the FDA) to support conducting a larger scale clinical trial for commercial approval. In either case, only de-identified data would not be used. The de-identified data of this study will not be provided to journals. The
data from this study will not be used for any future clinical studies.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.