Bariatric SurgeryRiMiniNCT05472922
The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
A study testing Placement of MiniMizer Gastric Ring and Normal MGB-OAGB in people with Bariatric Surgery and Weight Loss, run by Marc van Det at 1 site in Netherlands.
Trial summary
Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Weight Loss, Comorbidities and Coexisting Conditions
- What is being tested?
- Placement of MiniMizer Gastric Ring and Normal MGB-OAGB
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meet IFSO criteria for Bariatric Surgery
- Age 18 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Ziekenhuisgroep Twente
Almelo
Marc J van Det, MD PhD, +31887087878, m.vdet@zgt.nl
Maureen W Tissik, MD, +31887087878, m.tissink@zgt.nl
About this study
Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring.
Study design: A prospective non blinded single centre randomized controlled trial.
Read more
Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2.
Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB.
Main study parameters/endpoints:
Primary Objective:
- %TBWL 5 years after surgery. Secondary Objectives:
- Percentage Excess Weight Loss (%EWL) 5 years after surgery.
- Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).
- Improvement of quality of life: SF-36 and OBESI-Q questionnaires.
- Incidence and severity of dumping syndrome.
- Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.
- Incidence and complications due to silicone band.
Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:
Expected advantages of bOLGB versus OLGB:
- Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight.
- Long term decrease of weight regain.
- Decrease of incidence of dumping.
Possible disadvantages of bOLGB versus OLGB:
- Band-related complications such as erosion, infection, stenosis, or pouch dilatation.
- Functional gastro-intestinal complains such as dysphagia and reflux.
- Being tested
- Placement of MiniMizer Gastric Ring, Normal MGB-OAGB
- Keywords
- MGB-OAGB, MiniMizer Ring, banded bypass
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of MiniMizer Gastric RingDevice
Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB
Normal MGB-OAGBProcedure or surgery
No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB
| Study group | Role | What they receive |
|---|---|---|
| Banded Mini Gastric Bypass | Experimental | Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein Switzerland) Receives: Device: Placement of MiniMizer Gastric Ring |
| non-Banded Mini Gastric Bypass | Active comparator | Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) Receives: Procedure: Normal MGB-OAGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Weight Change 5 years after surgery
Percentage total body weight change 5 years after the procedure
Measured: 5 Years
Secondary outcomes (6)
Change in Percentage Excess Weight (%EWL) 5 years after surgery
Change in Percentage Excess Weight (%EWL)
Measured: 5 years
Change in (existing) co-morbidities 5 years after surgery
Change in severity of obesity-related co-morbidities: Type 2 Diabetes Mellitus (changes in HbA1c or use of antidiabetic medication), Hypertension (changes in bloodpressure or changes in use of antihypertensives), Osteo-arthritis (changes in VAS-score or use of analgesia drugs) , Hyperlipidemia (changes in HDL/LDL ratio, triglycerides or use of statine drugs), Obstructive Sleep Apnea syndrome (changes in use of CPEP treatment or changes is apneu hypopneu idex), and Gastro-Esophageal Reflux Disease (Changes in outcomes of GERD-HR questionnnaire which scoring scale runs from 0 (asymptomatic) to 50 (complete prohibitive) or changes in use of protonpompinhibitors)
Measured: 5 years
Outcome measurement of SF-36 questionnaire
Evalution of changes in outcome of SF-36 Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare
Measured: 5 years
Outcome measurement of OBESI-Q questionnaire
Evalution of changes in outcome of OBESI-Q Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare
Measured: 5 years
Dumping Syndrome
The presence and severity of complains related to Dumping Syndrome in participants (yes or no)
Measured: 5 years
Complications
The occurrence of short- and long-term complications of the minimizer ring
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded prospective randomized controlled single center trial.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc van Det
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuisgroep Twente
- Responsible party
- Sponsor-investigator, Marc van Det, Ziekenhuisgroep Twente
- Investigators
- Marc J van Det, MD PhD, Principal investigator, ZiekenhuisGroup Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472922
- Sponsor's protocol ID
- R22.025
- Acronym
- RiMini
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant data will not be shared.
Publications
Tissink M, Verhagen T, Faneyte I, Hazebroek E, Oost S, Timmerman J, Veldhuis A, van Det M. The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial. Obes Surg. 2025 May;35(5):1854-1859. doi: 10.1007/s11695-025-07751-6. Epub 2025 Mar 14.
PubMed 40085187
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05472922
- Acronym / sponsor ID
- RiMini / R22.025
- Keywords
- MGB-OAGB, MiniMizer Ring, banded bypass
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Marc van DetUniversity, hospital or other
- Collaborators
- Ziekenhuisgroep Twente
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Jul 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.
Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring.
Study design: A prospective non blinded single centre randomized controlled trial.
Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2.
Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB.
Main study parameters/endpoints:
Primary Objective:
- %TBWL 5 years after surgery. Secondary Objectives:
- Percentage Excess Weight Loss (%EWL) 5 years after surgery.
- Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).
- Improvement of quality of life: SF-36 and OBESI-Q questionnaires.
- Incidence and severity of dumping syndrome.
- Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.
- Incidence and complications due to silicone band.
Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:
Expected advantages of bOLGB versus OLGB:
- Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight.
- Long term decrease of weight regain.
- Decrease of incidence of dumping.
Possible disadvantages of bOLGB versus OLGB:
- Band-related complications such as erosion, infection, stenosis, or pouch dilatation.
- Functional gastro-intestinal complains such as dysphagia and reflux.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded prospective randomized controlled single center trial.
| Arm | Type | Receives |
|---|---|---|
| Banded Mini Gastric Bypass | Experimental | Device: Placement of MiniMizer Gastric RingPatients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein Switzerland) |
| non-Banded Mini Gastric Bypass | Active comparator | Procedure: Normal MGB-OAGBPatients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients meet IFSO criteria for Bariatric Surgery
- Age 18 and above
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Placement of MiniMizer Gastric RingInsertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB | Device | Banded Mini Gastric Bypass |
| Normal MGB-OAGBNo insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB | Procedure or surgery | non-Banded Mini Gastric Bypass |
Primary outcome
Total Body Weight Change 5 years after surgery
Time frame: 5 Years
Percentage total body weight change 5 years after the procedure
6 secondary outcomes
Change in Percentage Excess Weight (%EWL) 5 years after surgery
Time frame: 5 years
Change in (existing) co-morbidities 5 years after surgery
Time frame: 5 years
Outcome measurement of SF-36 questionnaire
Time frame: 5 years
Outcome measurement of OBESI-Q questionnaire
Time frame: 5 years
Dumping Syndrome
Time frame: 5 years
Complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 40085187Tissink M, Verhagen T, Faneyte I, Hazebroek E, Oost S, Timmerman J, Veldhuis A, van Det M. The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial. Obes Surg. 2025 May;35(5):1854-1859. doi: 10.1007/s11695-025-07751-6. Epub 2025 Mar 14.
- Individual participant dataSharing planned: No. Individual Participant data will not be shared.
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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.
Marc J van Det, MD PhD principal investigator
ZiekenhuisGroup Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of MiniMizer Gastric Ring and Normal MGB-OAGB in people with Bariatric Surgery and Weight Loss, run by Marc van Det at 1 site in Netherlands.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc J van Det, MD PhD (+31887087878, m.vdet@zgt.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Body Weight Change 5 years after surgery (time frame: 5 Years). 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 NCT05472922, which also lists 1 linked publication.
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 25 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.