Side-to-side anastomosis duodeno-ileostomy diversion procedure for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hospital Clinico San Carlos Complutense University of Madrid, Madrid, SpainObesitySide-to-side anastomosis duodeno-ileostomy diversion procedure - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new weight-loss surgery method on up to 35 obese people with or without diabetes. The surgery will be done using the MAGNET System, and patients will be followed for 12 months.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 360

Day 30
Proportion of subjects that meet all of the following 3 criteria: Placement of the MAGNET System ( 90% alignment of magnets); Passage of magnets without surgical re-intervention; and creation of a patent anastomosis, confirmed radiologically
Day 360
Efficacy in Body Weight reduction
Day 90
Safety evaluated by Incidence of treatment emergent AEs.

Trial Safety

Safety Progress

1 of 3

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1
Esophagectomy
2
MBL949 Arm 4
1
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Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Side-to-side anastomosis duodeno-ileostomy diversion procedure · No Placebo Group · N/A

Treatment
Device
Experimental Group · 1 Intervention: Side-to-side anastomosis duodeno-ileostomy diversion procedure · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 360

Who is running the clinical trial?

GT Metabolic Solutions, Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Obesity
10 Patients Enrolled for Obesity
Michel Gagner, MDPrincipal InvestigatorWestmount Surgical Center

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) between 30 and 50 and either have type 2 diabetes (HbA1c ≥ 6.5%), have regained weight after a previous sleeve gastrectomy, or are about to undergo a certain type of weight loss surgery.
References

Frequently Asked Questions

Could you tell me how many people are currently enrolled in this research project?

"That is correct, the clinical trial is ongoing and actively recruiting patients. The listing on clinicaltrials.gov shows that the trial was first posted on November 18th, 2021 and was last updated on April 4th, 2022. They are presently looking for 35 patients to participate at 2 sites." - Anonymous Online Contributor

Unverified Answer

What are the prerequisites for joining this clinical trial?

"This trial is looking for 35 obese adults, aged 18 to 65, who also meet the following requirements: type 2 diabetes mellitus (T2DM) diagnosed by a hemoglobin A1c (HbA1c) level of 6.5% or higher, previous sleeve gastrectomy at least 12 months prior with weight regain, no previous sleeve gastrectomy but T2DM diagnosis, scheduled laparoscopic SADI-S procedure where duodeno-ileostomy is performed side-to-side with the MAGNET System and BMI of 40 or higher. Additionally, participants must agree not to have any additional" - Anonymous Online Contributor

Unverified Answer

Are we currently enrolling patients in this research?

"This trial, which was first advertised on November 18th 2021, is still recruiting patients according to the latest update from clinicaltrials.gov on April 4th, 2022." - Anonymous Online Contributor

Unverified Answer

Does this research project allow people who are over the age of 40 to enroll?

"In order to take part in this clinical trial, patients must be between 18-65 years old. There are 208 separate medical studies for individuals under 18 and 616 for those over 65." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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