ObesityNCT02528565
Gastric Banding After Failed Gastric Bypass
An observational study of Obesity, run by Duomed at 1 site in Belgium.
Trial summary
The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Adhesix Bioring
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2015to 9 Dec 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with failed RYGB receiving revisional LAGB.
Who may be able to join
- Patient must sign the informed consent form prior to the index-procedure.
- Patient with failed RYGB defined as patients with EWL <50%.
Who cannot join
- Patient has a life expectancy of less than 2 year.
- Patient who is most likely expected not to be compliant with the proposed follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center
The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.
- Conditions
- Obesity
- Being tested
- Adhesix Bioring
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesix BioringDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with failed RYGB (EWL <50%) | Not described Receives: Device: Adhesix Bioring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage excess weight loss
Measured: 2 years
Secondary outcomes (6)
Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.
Measured: During procedure
Complications (perioperative, early and late)
Measured: 2 years
Mortality
Measured: 2 years
Regression of co-morbidities
Measured: 2 years
BAROS score
Measured: 2 years
Frequency of revisions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
- Investigators
- Bruno Dillemans, MD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528565
- Sponsor's protocol ID
- BM-BA-01
- Status last verified
- Feb 2019
- First submitted
- 15 Jul 2015
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Adjustable Gastric Banding With the Adhesix Bioring After Failed Gastric Bypass: a Prospective Evaluation in a High-volume Center
- ClinicalTrials.gov ID
- NCT02528565
- Acronym / sponsor ID
- BM-BA-01
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- Aug 2015 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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 safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with failed RYGB (EWL <50%) | – | Device: Adhesix Bioring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with failed RYGB receiving revisional LAGB.
Key inclusion criteria (2 listed)
- Patient must sign the informed consent form prior to the index-procedure.
- Patient with failed RYGB defined as patients with EWL <50%.
Key exclusion criteria (2 listed)
- Patient has a life expectancy of less than 2 year.
- Patient who is most likely expected not to be compliant with the proposed follow-up visits.
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 |
|---|---|---|
| Adhesix Bioring | Device | Patients with failed RYGB (EWL <50%) |
Primary outcome
Percentage excess weight loss
Time frame: 2 years
6 secondary outcomes
Technical success defined as laparoscopic implantation of the Adhesix Bioring as intended by the surgeon without conversion to open repair.
Time frame: During procedure
Complications (perioperative, early and late)
Time frame: 2 years
Mortality
Time frame: 2 years
Regression of co-morbidities
Time frame: 2 years
BAROS score
Time frame: 2 years
Frequency of revisions
Time frame: 2 years
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 18 Jun 2020.
Related trials for Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Bruno Dillemans, MD principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Duomed at 1 site in Belgium.
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 2 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 18 Jun 2020. 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 Belgium. 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?
Percentage excess weight loss (time frame: 2 years). 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 18 Jun 2020.