Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000505606
Ethics application status
Approved
Date submitted
26/04/2023
Date registered
17/05/2023
Date last updated
21/04/2024
Date data sharing statement initially provided
17/05/2023
Date results information initially provided
21/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The ENIVO™ Study.
Pilot Safety Assessment of the ENIVO™ System in Patients Undergoing Simple Unilateral Mastectomy
Scientific title
Pilot Evaluation of the ENIVO System in Simple Unilateral Mastectomy
Secondary ID [1] 309458 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 329713 0
Condition category
Condition code
Surgery 326610 326610 0 0
Other surgery
Cancer 326802 326802 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Product used for intervention: ENIVO™ System (‘ENIVO’)
Patients undergoing simple mastectomy that would typically receive a surgical drain as part of their standard of care will receive an ENIVO™ System (‘ENIVO’). The ENIVO system is a new type of device that may aid in the removal of fluid from a surgical site and reduce the risk of fluid (seroma) formation. The ENIVO system is a battery-operated vacuum device that acts to remove fluids from around the surgical site and replaces traditional surgical drains, that would have been used as part of a simple mastectomy procedure. The main differences between a traditional surgical drain and the ENIVO system are:
• The ENIVO system is battery operated while a normal surgical drain is not.
• The ENIVO system includes a small patch of sterile material that is made from animal (sheep) tissue and is designed to sit between the silicon drain tube and the tissues of the surgical site.
A Primary Investigator, Sub Investigator (surgeons) and Study Team have undergone training to use the ENIVO device as part of a simple mastectomy procedure. This training was completed at least 5 weeks prior to the enrolment of the first participant and included placement of the ENIVO device, operation and maintenance and follow-up care.
Participants will undergo a screening that includes medical history review. The anticipated duration of screening visit is <60 mins. Once screening is complete, participants will undergo simple unilateral mastectomy, per the surgeon's typical protocol. During the surgical procedure you will have an ENIVO system placed in the surgical site rather than a normal surgical drain. The surgeon will only use one ENIVO system during your surgery. Using the ENIVO system instead of a standard surgical drain will not change your surgery, the time of the surgery, or the length of your hospital stay. With the ENIVO implant device being placed intra-operatively the anticipated duration of surgery is ~120 mins.
All participants shall receive standard post-operative care.
All patients shall remain in-patient overnight, and then may be discharged at the surgeon’s discretion. Participants will return to the clinic for follow-up visits at:
Short-term Post-operative:
• 1 week post-operative (±2 days) (‘dressing change assessment’)
• <2 weeks post-operative (‘drain removal assessment’) Long-term Post-operative:
• 1 week (±2 days) post drain removal (‘imaging assessment’) (~ 3 weeks post-operative)
• 3 months (‘long term follow-up assessment’)
These visits will be conducted in person. Participants and the research team will answer structured questions relating to the performance of the ENIVO system, including fluid output volume, which shall be recorded daily.
Surgical drains are typically removed <14 days after a mastectomy procedure, and clinical decision making is based on the daily fluid output (mL). Fluid output shall be recorded by the Study Team during the course of post-operative treatment. At the discretion of the Investigator, ENIVO drainage catheters will be removed when daily drain fluid output is <30 mL/24 hour. In the event that drain fluid volume does not reach <30 mL/24 hour within 14 days, drain removal shall fall to the discretion of the Investigator and Surgeon. The time to drain removal (days) shall be recorded by the study team.
During the course of treatment (out to and including 3-month long-term follow-up) surgical site occurrences (SSO) will be monitored and recorded. SSO shall include those commonly associated with post-operative complications, including seroma, hematoma, infection, lymphedema, tissue necrosis, dehiscence.
During follow-up visits patients will also be asked to qualitatively score their pain. Participants will be asked to complete structured questionnaires to assess the ENIVO system useability and functionality during the dressing change assessment and drain removal assessment.
De-identified photographs will be taken for documentation purposes. An intra-operative photo will be taken by the Study Team to illustrate surgical placement of the ENIVO device. At subsequent post- operative visits, the wound and drain site will be photographed. No photographs will show the participants face. Any distinguishing features (e.g., tattoos) will be removed or obscured from the digital images.
Intervention code [1] 325880 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334468 0
Frequency of Adverse Device Effects and Serious Adverse Device Effects during the course of ENIVO treatment will be assessed by clinical examination and data-linkage to medical records.
Timepoint [1] 334468 0
•1 week post-surgery (±2 days) (‘dressing change assessment’)
• <2 weeks post-surgery ‘drain removal assessment’ at discretion of Surgeon
Secondary outcome [1] 420796 0
Daily fluid collection volume and cumulative fluid collection volume.
Both measures will be assessed in the form of composite secondary outcome.
During inpatient stay the data will be recorded by the study nurse in study CRF by assessing fluid output and/or reviewing medical records.
Once participant is home the Study Team will contact participant by phone every 1-2 days. A Participant will be asked to weigh the amount of fluid that the ENIVO system has collected. This information will be handwritten in a questionnaire form by the Study Team.
Timepoint [1] 420796 0
Post-surgical daily assessment up to drain removal. (Day 1 to ~13)
Secondary outcome [2] 420797 0
Mean time (days) to drain removal. The data will be collected by study nurse by reviewing medical records.
Timepoint [2] 420797 0
<2 weeks post-surgery ‘drain removal assessment’ at discretion of Surgeon and based on the daily fluid output (ml).
Secondary outcome [3] 420798 0
Frequency of post-operative complications (i.e., seroma, hematoma, dehiscence, infection) prior to long term follow-up (3 months).
Post-operative complications will be assessed by study nurse/doctor performing a physical examination of surgical site and reviewing of medical records.
Timepoint [3] 420798 0
1week (±2 days) after Drain Removal (~ 3 weeks post-surgery)
Secondary outcome [4] 420799 0
Patients Post-operative pain will be measured (score 0 through 10)
This outcome will be assessed by visual analogue scale using scores 0-10.
Timepoint [4] 420799 0
At Dressing Change Assessment (Day 7 post-surgery),
At Drain Removal Assessment (<2 weeks post-surgery),
At Imaging Assessment (~3 weeks post-surgery),
At Long-term Assessment (~3 months post-surgery)
Secondary outcome [5] 420800 0
LOS (Length of Stay)
This data will be collected by review of medical records by the study team.
Timepoint [5] 420800 0
Mean time (days) to discharged from the hospital.

Eligibility
Key inclusion criteria
Patients will be considered eligible for the study based on the following criteria:
• Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan.
• Aged 21 years or above.
• Undergoing simple unilateral mastectomy, with or without sentinel node biopsy and who would otherwise be receiving surgical drains as part of standard of care.
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study based on the following criteria:
• Patients with known sensitivity to ovine (sheep) derived material, silicon, barium sulphate or synthetic suture materials.
• Pregnant or lactating females.
• Patients on steroids or other immune modulators known to impact healing.
• Patients who are likely to not complete the study.
• Patients who, in the opinion of the investigator, are unlikely to comply with the protocol.
• Patients who have participated in this trial previously and who were withdrawn.
• Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study, such as obesity (BMI>40), uncontrolled diabetes (HbA1c>53 mmol/mol), immunosuppression, or recent neoadjuvant chemotherapy or radiotherapy.
• Patient is currently participating or has participated in another clinical study within past 30 days prior to enrolment.
• Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Patient demographics, baseline defect assessment characteristics, intra- and postoperative attributes will be summarized using standard descriptive statistics including means, medians, standard deviations and ranges or frequencies and percentages as appropriate.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
17/07/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
26/03/2024
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 25399 0
New Zealand
State/province [1] 25399 0
Auckland

Funding & Sponsors
Funding source category [1] 313653 0
Commercial sector/Industry
Name [1] 313653 0
Aroa Biosurgery Ltd
Country [1] 313653 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Aroa Biosurgery Ltd.
Address
64 Richard Pearse Drive, Mangere, Auckland 2022
Country
New Zealand
Secondary sponsor category [1] 315445 0
None
Name [1] 315445 0
Address [1] 315445 0
Country [1] 315445 0
Other collaborator category [1] 282630 0
Other Collaborative groups
Name [1] 282630 0
Aotearoa Clinical Trials
Address [1] 282630 0
Te Whatu Ora Counties Manukau, Middlemore Hospital,
100 Hospital Road, Auckland 2025
Country [1] 282630 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312821 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 312821 0
Ministry of Health
133 Molesworth Street, Wellington 6011
Ethics committee country [1] 312821 0
New Zealand
Date submitted for ethics approval [1] 312821 0
01/12/2022
Approval date [1] 312821 0
23/12/2022
Ethics approval number [1] 312821 0
2022 FULL 13814

Summary
Brief summary
The ENIVO system is a new type of device that may aid in the removal of fluid from a
surgical site and reduce the risk of seroma formation.
The principal objective of the proposed study is to test the safety and performance of the ENIVO system in a small group of patients who would be undergoing simple mastectomy and would otherwise be receiving a standard of care surgical drain during their procedure. As this is a first in human study a small sample size has deliberately been chosen, and there is no randomization. The study outcomes include:
-assessment of any adverse events related to use of the ENIVO system
-the performance of the ENIVO device, as evidenced by the formation of any post-operative seroma in any of the patients.
Trial website
https://www.aotearoatrials.nz/recruiting-trials
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126038 0
Dr Michelle Locke
Address 126038 0
Auckland Regional Plastic Reconstructive and Hand Surgery
Middlemore Hospital
100 Hospital Road, Otahuhu.
Private Bag 93311
Otahuhu, Auckland 1640
Country 126038 0
New Zealand
Phone 126038 0
+64092760044
Fax 126038 0
Email 126038 0
michelle.locke@middlemore.co.nz
Contact person for public queries
Name 126039 0
Dr Michelle Locke
Address 126039 0
Auckland Regional Plastic Reconstructive and Hand Surgery
Middlemore Hospital
100 Hospital Road, Otahuhu.
Private Bag 93311
Otahuhu, Auckland 1640
Country 126039 0
New Zealand
Phone 126039 0
+64 092760000
Fax 126039 0
Email 126039 0
michelle.locke@middlemore.co.nz
Contact person for scientific queries
Name 126040 0
Dr Michelle Locke
Address 126040 0
Auckland Regional Plastic Reconstructive and Hand Surgery
Middlemore Hospital
100 Hospital Road, Otahuhu.
Private Bag 93311
Otahuhu, Auckland 1640
Country 126040 0
New Zealand
Phone 126040 0
+64 092760000
Fax 126040 0
Email 126040 0
michelle.locke@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To ensure patient privacy, individual participant data for this trial will not be available.


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.