ObesityNCT05322122
Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System
A study testing Side-to-side anastomosis duodeno-ileostomy diversion procedure in people with Obesity, run by GT Metabolic Solutions, Inc. at 4 sites in 4 countries.
Trial summary
This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Side-to-side anastomosis duodeno-ileostomy diversion procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 18 Nov 2021to 4 Apr 2024
- 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
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-50, inclusive with either:
- Previous-sleeve gastrectomy (> 12 months) with either T2DM (defined as HbA1c > 6.5%) or weight regain; or
- T2DM without previous gastrectomy; or
- Undergoing laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) where duodeno-ileostomy is performed side to side with the MAGNET System and BMI > 40
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for 1 year
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for 1 year
- Willing and able to comply with protocol requirements
Who cannot join
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Uncontrolled hypertension, dyslipidemia or sleep apnea
- Prior intestinal, colonic or duodenal surgery, other than bariatric
- Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra- indicate the procedure, including scarring and abnormal anatomy
Show all 32Show fewer
- Refractory gastro-esophageal reflux disease (GERD)
- Barrett's disease
- Helicobacter pylori positive and/or active ulcer disease
- Large hiatal hernia
- Inflammatory bowel or colonic diverticulitis disease
- Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques
- Implantable pacemaker or defibrillator
- Psychiatric disorders, except well-controlled depression with medication for >6mo, or history of substance abuse
- Woman who is either pregnant or breast feeding
- Woman of childbearing potential who does not agree to use an effective method of contraception
- Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure. This includes any conditions for which endoscopic or laparoscopic surgery would be contraindicated, and any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
- Unhealed ulcers, bleeding lesions, tumor or any other lesion at target magnet deployment site
- Expected need for MR imaging within the first 2 months after the procedure
- Any anomaly preventing/contraindicating laparoscopic access and general laparoscopic procedures
- Had surgical or interventional procedure within 30 days prior to procedure
- Any scheduled surgical or interventional procedure planned within 30 days post-procedure
- Any stroke/TIA within 6 months prior to consent
- Requires chronic anticoagulation therapy (except aspirin)
- Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
- Unable to comply with the follow-up schedule and assessments
- Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
- Known allergies to the device components or contrast media
- Limited life expectancy due to terminal disease
- Currently participating in another clinical research study with an investigational drug or medical device
- A positive COVID-19 test prior to the study procedure
- Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Spain1 site
Hospital Clinico San Carlos Complutense University of Madrid
Madrid, 28040
About this study
Official title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (MAGNET System) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus
This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.
Read the detailed description
The MAGNET study is an operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe as follows:
- Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and
- Stage 2 feasibility with 45 subjects.
There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
Study Procedure: Side-to-side anastomosis duodeno-ileostomy diversion procedure using the MAGNET System
Study Population: Adults (18 to 65 years of age, inclusive) with obesity (BMI 30-50) who meet one of the following criteria: (1) have type 2 diabetes mellitus (T2DM) or experienced weight regain following previous sleeve gastrectomy; (2) have T2DM without previous sleeve gastrectomy; or (3) are candidates for a laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) procedure and have BMI ≥ 40.
Follow-up: Each subject will return for 6 follow-up visits at Day 14, 30, 60, 90, 180, 270 and 360 (end of study).
- Conditions
- Obesity
- Being tested
- Side-to-side anastomosis duodeno-ileostomy diversion procedure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side-to-side anastomosis duodeno-ileostomy diversion procedureDevice
Also called The MAGNET System
Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Side-to-side anastomosis duodeno-ileostomy diversion Receives: Device: Side-to-side anastomosis duodeno-ileostomy diversion procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and performance measured by anastomosis success
The primary feasibility/performance endpoint is the feasibility/performance of side-to-side anastomosis duodeno-ileostomy defined as:
- Placement of the MAGNET System (≥ 90% alignment of magnets); and
- Passage of magnets without surgical re-intervention; and
- Creation of a patent anastomosis, confirmed radiologically.
The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
Measured: Day 90
Secondary outcomes (4)
To evaluate the safety of the MAGNET System
The incidence of treatment emergent AEs and SAEs is a standard measure of the safety.
The incidence of device malfunction informs about the device reliability.
Measured: Day 30, 90, 180, and 360
Efficacy of weight loss
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in total weight loss and excess weight loss (EWL)
Measured: Day 90, 180, and 360
Efficacy of metabolic improvement
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in functional improvement of metabolic indicators (HbA1c, blood glucose)
Measured: Day 90, 180, and 360
Quality of life improvement
Efficacy will be assessed at Day 90, 180 and 360 based on change from baseline in quality of life improvement (SF-36)
Measured: Day 90, 180, and 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start18 Nov 2021
- Primary completion22 Jun 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- An operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe: * Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and * Stage 2 feasibility with 45 subjects. There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Gagner, MD, Principal investigator, Westmount Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322122
- Sponsor's protocol ID
- GTM-001
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dziakova J, Torres A, Odovic M, Esteban JM, Vazquez-Romero M, Castillo A, Sanchez-Pernaute A, Gagner M. Spanish Experience with Latero-Lateral Duodeno-Ileostomy + Sleeve Gastrectomy with Magnet Anastomosis System. Obes Surg. 2024 Sep;34(9):3569-3575. doi: 10.1007/s11695-024-07432-w. Epub 2024 Aug 2.
PubMed 39093385Gagner M, Almutlaq L, Gnanhoue G, Buchwald JN. Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes. World J Surg. 2024 Oct;48(10):2337-2348. doi: 10.1002/wjs.12304. Epub 2024 Aug 1.
PubMed 39090770Gagner M, Abuladze D, Koiava L, Buchwald JN, Van Sante N, Krinke T. First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023 Aug;33(8):2282-2292. doi: 10.1007/s11695-023-06708-x. Epub 2023 Jul 2.
PubMed 37393568
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. 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 Magnetic Anastomosis System (MAGNET System) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and With or Without Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05322122
- Acronym / sponsor ID
- GTM-001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 11 Apr 2022 (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.
This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.
Detailed description
The MAGNET study is an operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe as follows:
- Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and
- Stage 2 feasibility with 45 subjects.
There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
Study Procedure: Side-to-side anastomosis duodeno-ileostomy diversion procedure using the MAGNET System
Study Population: Adults (18 to 65 years of age, inclusive) with obesity (BMI 30-50) who meet one of the following criteria: (1) have type 2 diabetes mellitus (T2DM) or experienced weight regain following previous sleeve gastrectomy; (2) have T2DM without previous sleeve gastrectomy; or (3) are candidates for a laparoscopic single anastomosis duodenal-ileal bypass with sleeve (SADI-S) procedure and have BMI ≥ 40.
Follow-up: Each subject will return for 6 follow-up visits at Day 14, 30, 60, 90, 180, 270 and 360 (end of study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An operationally seamless, 2-stage, open-label, multicenter study enrolling up to 50 subjects at up to 5 study centers across Canada and Europe: * Stage 1 first-in-human (FIH) and proof-of-concept with 5 subjects; and * Stage 2 feasibility with 45 subjects. There will be a pause after completing enrollment in Stage 1 to allow completion of Day 30 and evaluation of safety by the independent Data Safety Monitoring Committee (DSMB). The DSMB will confirm whether the study can advance to Stage 2. All subjects in Stage 1 and 2 will be followed for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Side-to-side anastomosis duodeno-ileostomy diversion procedureSide-to-side anastomosis duodeno-ileostomy diversion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age, inclusive, at the time of informed consent
- BMI 30-50, inclusive with either:
- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for 1 year
- If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for 1 year
- Willing and able to comply with protocol requirements
Key exclusion criteria (32 listed)
- Type 1 diabetes
- Use of injectable insulin
- Uncontrolled T2DM
- Uncontrolled hypertension, dyslipidemia or sleep apnea
- Prior intestinal, colonic or duodenal surgery, other than bariatric
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 |
|---|---|---|
| Side-to-side anastomosis duodeno-ileostomy diversion procedureAlso: The MAGNET SystemCreation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions Magnetic Anastomosis System (The MAGNET System) to Achieve Duodeno-Ileostomy Diversion. | Device | Treatment |
Primary outcome
Feasibility and performance measured by anastomosis success
Time frame: Day 90
The primary feasibility/performance endpoint is the feasibility/performance of side-to-side anastomosis duodeno-ileostomy defined as: * Placement of the MAGNET System (≥ 90% alignment of magnets); and * Passage of magnets without surgical re-intervention; and * Creation of a patent anastomosis, confirmed radiologically. The primary endpoint will be met if the feasibility/performance is confirmed in ≥ 80% of enrolled and treated subjects.
4 secondary outcomes
To evaluate the safety of the MAGNET System
Time frame: Day 30, 90, 180, and 360
Efficacy of weight loss
Time frame: Day 90, 180, and 360
Efficacy of metabolic improvement
Time frame: Day 90, 180, and 360
Quality of life improvement
Time frame: Day 90, 180, and 360
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 21 Jun 2024.
- Derived from this study: PubMed 39093385Dziakova J, Torres A, Odovic M, Esteban JM, Vazquez-Romero M, Castillo A, Sanchez-Pernaute A, Gagner M. Spanish Experience with Latero-Lateral Duodeno-Ileostomy + Sleeve Gastrectomy with Magnet Anastomosis System. Obes Surg. 2024 Sep;34(9):3569-3575. doi: 10.1007/s11695-024-07432-w. Epub 2024 Aug 2.
- Derived from this study: PubMed 39090770Gagner M, Almutlaq L, Gnanhoue G, Buchwald JN. Magnetic single-anastomosis side-to-side duodeno-ileostomy for revision of sleeve gastrectomy in adults with severe obesity: 1-year outcomes. World J Surg. 2024 Oct;48(10):2337-2348. doi: 10.1002/wjs.12304. Epub 2024 Aug 1.
- Derived from this study: PubMed 37393568Gagner M, Abuladze D, Koiava L, Buchwald JN, Van Sante N, Krinke T. First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023 Aug;33(8):2282-2292. doi: 10.1007/s11695-023-06708-x. Epub 2023 Jul 2.
- 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.
Michel Gagner, MD principal investigator
Westmount Surgical Center
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Side-to-side anastomosis duodeno-ileostomy diversion procedure in people with Obesity, run by GT Metabolic Solutions, Inc. at 4 sites in 4 countries.
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 8 inclusion and 32 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 21 Jun 2024. 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 Belgium, Canada, Georgia, Spain. 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 measured by anastomosis success (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322122, which also lists 3 linked publications.
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 21 Jun 2024.