ObesityNCT06613711
MagDI Italian Study
A study testing Magnet System, DI Biofragmentable in people with Obesity and Type 2 Diabetes Mellitus (T2DM), run by GT Metabolic Solutions, Inc. at 4 sites in Italy.
Trial summary
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus (T2DM), Anastomosis
- What is being tested?
- Magnet System, DI Biofragmentable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesItaly
- Study dates
- 20 Sep 2024to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
- Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
- Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.
- 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.
Who cannot join
- 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
- gt; 6 months. 17. History of substance abuse. 18. Pregnant, lactating, or planning pregnancy during the clinical investigation.
Show all 18Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Policlinico San Marco
Bergamo
Maria Cecilia Hispital
Cotignola
San Raffaelle Hospital
Milan
Ospedale Evangelco Betania
Naples
About this study
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Italy to Achieve Duodeno-Ileal Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Italy Study)
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
Read the detailed description
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
The partial diversion of intestinal contents from the duodenum to the ileum via side-to-side duodeno-ileostomy is intended to facilitate weight management / loss in obese adults and improve metabolic outcomes in obese adults with or without type 2 diabetes mellitus (T2DM). Side-to-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. The most common side-to-side anastomosis technique used today is stapling, requiring cutting of the intestines and staples remain behind in the body. Linear staplers are available in different sizes (e.g., 30mm, 45mm, 50mm, 60mm). A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.
- Conditions
- Obesity, Type 2 Diabetes Mellitus (T2DM), Anastomosis
- Being tested
- Magnet System, DI Biofragmentable
- Keywords
- GT Metabolic, Magnetic Anastomosis, MagDI System
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet System, DI BiofragmentableDevice
Anastomoses achieved by magnetic compression.
| Study group | Role | What they receive |
|---|---|---|
| Magnet System, DI Biofragmentable | Experimental | GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) Receives: Device: Magnet System, DI Biofragmentable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
The duodeno-ileal diversion will be considered feasible if it results in successful:
- Placement of the Magnet System (≥ 90% alignment of magnets); and
- Creation of a patent anastomosis confirmed radiologically, and
- Passage of magnets without any surgical re-interventions.
The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
Measured: From date of study index procedure through 90 days
Safety of the MagDI System
Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: • All-cause mortality • Intestinal perforation and/or peritonitis • Intestinal obstruction • Life-threatening bleeding • Incidence of device malfunctions
Measured: Procedure, Day 90, Day 180, Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Sep 2024
- Primary completion17 Jun 2025
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label multicenter study enrolling up to 60 participants at up to 5 sites in Italy.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613711
- Sponsor's protocol ID
- GTM-010
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) in Italy to Achieve Duodeno-Ileal Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus (MagDI Italy Study)
- ClinicalTrials.gov ID
- NCT06613711
- Acronym / sponsor ID
- GTM-010
- Conditions
- Obesity, Type 2 Diabetes Mellitus (T2DM), Anastomosis
- Keywords
- GT Metabolic, Magnetic Anastomosis, MagDI System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
Detailed description
The objective of the MagDI Italy Study is to evaluate the feasibility / performance, safety, and initial efficacy of the MagDI System in eligible participants who are indicated for a duodeno-ileal (small bowel) side-to-side anastomosis procedure for partial intestinal diversion (e.g., one example of a small bowel clinical procedure requiring a side-to-side anastomosis).
The partial diversion of intestinal contents from the duodenum to the ileum via side-to-side duodeno-ileostomy is intended to facilitate weight management / loss in obese adults and improve metabolic outcomes in obese adults with or without type 2 diabetes mellitus (T2DM). Side-to-side anastomoses are currently created by sutures, staples, and anastomotic compression devices. The most common side-to-side anastomosis technique used today is stapling, requiring cutting of the intestines and staples remain behind in the body. Linear staplers are available in different sizes (e.g., 30mm, 45mm, 50mm, 60mm). A predicate for this side-to-side duodeno-ileostomy diversion procedure is the single-anastomosis duodeno-ileostomy (SADI) procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label multicenter study enrolling up to 60 participants at up to 5 sites in Italy.
| Arm | Type | Receives |
|---|---|---|
| Magnet System, DI Biofragmentable | Experimental | Device: Magnet System, DI BiofragmentableGT Metabolic Solutions Magnet System, DI Biofragmentable (MagDI System) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous sleeve gastrectomy (≥ 12 months); OR
- Type 2 Diabetes Mellitus (T2DM; defined as HbA1c ≥ 6.5%) or weight regain following previous endoscopic sleeve gastroplasty (≥ 12 months); OR
- Type 2 Diabetes Mellitus (defined as HbA1c ≥ 6.5%) with a Body Mass Index between 30-35 and without previous sleeve gastrectomy and no plan to perform a concurrent sleeve gastrectomy.
- 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.
Key exclusion criteria (18 listed)
- 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
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnet System, DI BiofragmentableAnastomoses achieved by magnetic compression. | Device | Magnet System, DI Biofragmentable |
Primary outcome
Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System.
Time frame: From date of study index procedure through 90 days
The duodeno-ileal diversion will be considered feasible if it results in successful: * Placement of the Magnet System (≥ 90% alignment of magnets); and * Creation of a patent anastomosis confirmed radiologically, and * Passage of magnets without any surgical re-interventions. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
Safety of the MagDI System
Time frame: Procedure, Day 90, Day 180, Day 360
Freedom from serious adverse events related to the study device or study device procedure requiring additional emergency surgery or re-intervention, including: • All-cause mortality • Intestinal perforation and/or peritonitis • Intestinal obstruction • Life-threatening bleeding • Incidence of device malfunctions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet System, DI Biofragmentable in people with Obesity and Type 2 Diabetes Mellitus (T2DM), run by GT Metabolic Solutions, Inc. at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and performance of the side-to-side anastomosis for duodeno-ileal diversion using the MagDI System. (time frame: From date of study index procedure through 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.