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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06473831




Registration number
NCT06473831
Ethics application status
Date submitted
19/06/2024
Date registered
25/06/2024

Titles & IDs
Public title
MagDI Australia Study
Scientific title
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Australia to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With Type 2 Diabetes Mellitus (MagDI Australia Study)
Secondary ID [1] 0 0
GTM-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Magnet System, DI Biofragmentable

Experimental: Magnet System, DI Biofragmentable - GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System)


Treatment: Devices: Magnet System, DI Biofragmentable
Anastomoses achieved by magnetic compression.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
Timepoint [1] 0 0
From date of study index procedure through 90 days
Primary outcome [2] 0 0
Safety of the MagDI System
Timepoint [2] 0 0
Procedure, Day 90, Day 180, Day 360

Eligibility
Key inclusion criteria
1. Between 18-65 years of age, at the time of informed consent.
2. Body Mass Index (BMI) between 30-50 kg/m2
3. Meets one of the following criteria:

1. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c = 6.5%) following previous sleeve gastrectomy (= 12 months); OR
2. Type 2 Diabetes Mellitus (T2DM; defined as HbA1c = 6.5%) without previous sleeve gastrectomy and without plan to perform a concurrent sleeve gastrectomy.
3. Weight regain following previous sleeve gastrectomy (= 12 months).
4. Participant agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study.
5. Participant has been informed of the nature of the study and agrees to its provisions, complying with study required testing, medications, follow-up visits, and has provided written informed consent.
6. Participant is indicated for, and has agreed to, a bariatric procedure involving a duodenal ileal anastomosis. The participant has also undergone the site standard of care evaluation for this type of procedure, which is expected to involve clinical assessments over a period of time by a multidisciplinary team and may include, but is not limited to, the following: screening for surgical safety, interviews to determine if the participant understands the procedure and post-operative demands, and whether the participant has the necessary social supports in place to help manage outcomes.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes.
2. Use of injectable insulin.
3. Uncontrolled Type 2 Diabetes Mellitus (T2DM).
4. Investigator plans to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure.
5. Uncontrolled hypertension, dyslipidemia or sleep apnea.
6. Prior intestinal, colonic or duodenal surgery (other than bariatric).
7. Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the procedure, including scarring and abnormal anatomy.
8. Refractory gastro-esophageal reflux disease (GERD).
9. Barrett's disease.
10. Helicobacter pylori positive and/or active ulcer disease.
11. Large hiatal hernia.
12. Inflammatory bowel or colonic diverticulitis disease.
13. Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
14. Any anomaly preventing / contraindicating endoscopic or laparoscopic access and procedures.
15. Implantable pacemaker or defibrillator.
16. Psychiatric disorder, except well-controlled depression with medication for > 6 months.
17. History of substance abuse.
18. Pregnant, lactating, or planning pregnancy during the clinical investigation. Note: Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).
19. Any comorbidity or current status of participant's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the participant medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets.
20. Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment site.
21. Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months post-procedure.
22. Any surgical or interventional procedure (including planned and/or scheduled) within the period of 30 days prior to and 30 days following the study procedure.
23. Any stroke/TIA = 6 months prior to consent.
24. Requires chronic anticoagulation therapy (except aspirin).
25. Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
26. Recent tobacco or nicotine product cessation = 3 months prior to informed consent.
27. Known allergies to the device components (including the biofragmentable material PGLA or similar compounds) or contrast media.
28. Participants with comorbidities that are likely to result in a life expectancy of = 12 months.
29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint: Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
30. A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol.
31. Presence of other anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dr. Mark Magdy (affiliated with St. George Private Hospital) - Sydney
Recruitment hospital [2] 0 0
Upper GI Surgery - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GT Metabolic Solutions, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Griffin Vincent, PhD
Address 0 0
Country 0 0
Phone 0 0
+1 763-200-1416
Fax 0 0
Email 0 0
clinical@gtmetabolic.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06473831