Investigating weight loss after mini gastric bypass with a special ring
Official title: The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
Run by Ziekenhuisgroep Twente · NCT05472922 · Data updated 2026-11-12
This study is testing if a special ring used during mini gastric bypass surgery can help people lose a lot of weight and improve health issues related to obesity over five years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Ziekenhuisgroep Twente Academic / other |
| Locations | 1 site (Almelo) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | July 1, 2023 |
| Study ends | July 1, 2028 |
| Registry record updated | July 25, 2022 |
| Trial ID | NCT05472922 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a Body Mass Index (BMI) of 35 or higher and related comorbidities, or a BMI exceeding 40.
✕Probably not a fit
Patients who have previously undergone bariatric surgery or have certain medical conditions, such as severe kidney or liver disease, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a MiniMizer Ring implanted during a mini gastric bypass (MGB-OAGB) surgery in promoting significant weight loss over a five-year period. It is a prospective, non-blinded, single-center randomized controlled trial involving patients who meet specific criteria for bariatric surgery. The primary endpoint is the percentage of total body weight loss (%TBWL) five years post-surgery, with secondary objectives including the percentage of excess weight loss (%EWL) and the reduction of obesity-related comorbidities such as diabetes and hypertension.
Why it matters
Potential benefit: If successful, this approach could lead to improved long-term weight loss and better management of obesity-related health conditions for patients.
How similar studies have gone: Other studies have shown promising results with similar bariatric surgical approaches, but the specific combination of MGB-OAGB with the MiniMizer Ring is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients meet IFSO criteria for Bariatric Surgery * Age 18 and above Exclusion Criteria: * Previous Bariatric surgery * Inability to read and understand written information * Any genetic condition that can hamper the acceptance of medical advice * chronic bowel disease * Severe kidney of liver disease * Pregnancy at the start or during the research period * Patients with pre-existing therapy refractory GERD * Patients with an allergy to silicone
Where it's running
-
Ziekenhuisgroep Twente
Almelo, Netherlands Recruiting
Study contacts
- Principal investigator: Marc J van Det, MD PhD — ZiekenhuisGroup Twente
- Study coordinator: Marc J van Det, MD PhD
- Email: m.vdet@zgt.nl
- Phone: +31887087878
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.