Bariatric Surgery CandidateARG-BPNCT05149105
Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass
A study testing Argon plasma coagulation in people with Bariatric Surgery Candidate, run by Saint-Gregoire Private Hospital Center at 1 site in France.
Trial summary
Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Argon plasma coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2022to Jun 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
- Be between 18 and 65 years old.
- Have had a gastric bypass in Y more than 2 years ago
- Have a weight regain of more than 10% of the lowest weight after the first intervention.
- Have benefited from a multidisciplinary medico-psychological reassessment.
- Understand the interest of the study and agree to long-term follow-up.
- Agree to be included in the study and have signed a consent form in a free and informed manner.
- Be affiliated with health insurance.
- For female patients of childbearing potential, have an effective method of contraception
Who cannot join
- Presence of a disease unrelated to obesity that is life-threatening.
- Pregnancy or wish to become pregnant within the year.
- "Breastfeeding" patients
- Female patients of childbearing age and unable or unwilling to use an effective method of contraception
- Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
- Presence of a psychiatric pathology compromising the proper understanding of the study or patient under guardianship or guardianship.
- Patient not understanding French or unable to give consent.
- Patient already included in a study or in conflict of interest with this study.
Trial locations and contacts
1 site in 1 country.
Adrien STERKERS, MD contact
France1 site, 1 recruiting
- Recruiting
CHP Saint-Grégoire
Saint-Grégoire, 35760
Muriele BELLEC-FAGOT
About this study
Official title: Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.
Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Argon plasma coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon plasma coagulationProcedure or surgery
On D0, in the operating room, argon plasma coagulation will be performed around the perimeter of the anastomosis for a period of 5 to 10 min under general anesthesia. The removal of the catheter and the endoscope will be carried out under control. Patients will be kept under surveillance the night following the procedure. A liquid diet will be prescribed for 10 days. The follow-up will be carried out on an outpatient basis with a control endoscopy at 2 months, followed by a new procedure in the event of an anastomosis larger than 1.5 cm. A new endoscopic check will be carried out at 4 months if an argon plasma coagulation was performed during the previous check, with a third and last argon plasma coagulation if an anastomosis of more than 1.5 cm persists. The number of procedures will therefore be a maximum of 3. A control endoscopy will be performed at one year for the final control of the anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| APC intervention | Experimental | In addition to multidisciplinary care (standard care), patients benefit from an Argon Plasma Coagulation (APC) intervention at D0.
The APC intervention should be repeted at Month 2 and Month 4. Receives: Procedure: Argon plasma coagulation |
| Control | No intervention | Patients are treated according to standard care (multidisciplinary care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms
The percentage of excess weight loss (PEP%) will be measured according to the formula: PEP% = weight loss in kg * 100 / excess of initial weight. The initial excess weight is defined as the baseline weight - ideal weight.
Measured: Day 0 (before the intervention) and Months 12 (one year after Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start9 Jun 2022
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Gregoire Private Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149105
- Sponsor's protocol ID
- 2020-A02992-37
- Acronym
- ARG-BP
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Using Argon Plasma Coagulation in Weight Regain in Patients Following Gastric Bypass. Monocentric, Comparative, Randomized, Open Study.
- ClinicalTrials.gov ID
- NCT05149105
- Acronym / sponsor ID
- ARG-BP / 2020-A02992-37
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Saint-Gregoire Private Hospital CenterUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Dec 2021 (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.
Among the techniques of bariatric surgery, the gastric Y bypass according to Roux (RYGB) allows greater weight loss and more lasting over time than sleeve gastrectomy and gastric banding. However, around 20% of patients will regain weight within 24 months after surgery. Among the many mechanisms that lead to weight regain, we can mention distension of the gastric pouch and gastro-jejunal anastomosis. A reoperation is then necessary. Argan plasma coagulation intervention (APC) by endoscopy allows to reduce the caliber of the gastro-jejunal anastomosis. The aim of the study is to show the efficacy of APC associated with multidisciplinary medical management and to compare it with multidisciplinary medical management alone in weight regain of patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APC intervention | Experimental | Procedure: Argon plasma coagulationIn addition to multidisciplinary care (standard care), patients benefit from an Argon Plasma Coagulation (APC) intervention at D0. The APC intervention should be repeted at Month 2 and Month 4. |
| Control | No intervention | –Patients are treated according to standard care (multidisciplinary care). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between 18 and 65 years old.
- Have had a gastric bypass in Y more than 2 years ago
- Have a weight regain of more than 10% of the lowest weight after the first intervention.
- Have benefited from a multidisciplinary medico-psychological reassessment.
- Understand the interest of the study and agree to long-term follow-up.
Key exclusion criteria (8 listed)
- Presence of a disease unrelated to obesity that is life-threatening.
- Pregnancy or wish to become pregnant within the year.
- "Breastfeeding" patients
- Female patients of childbearing age and unable or unwilling to use an effective method of contraception
- Presence of an unhealed gastric ulcer or stenosis of the gastrointestinal anastomosis
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 |
|---|---|---|
| Argon plasma coagulationOn D0, in the operating room, argon plasma coagulation will be performed around the perimeter of the anastomosis for a period of 5 to 10 min under general anesthesia. The removal of the catheter and the endoscope will be carried out under control. Patients will be kept under surveillance the night following the procedure. A liquid diet will be prescribed for 10 days. The follow-up will be carried out on an outpatient basis with a control endoscopy at 2 months, followed by a new procedure in the event of an anastomosis larger than 1.5 cm. A new endoscopic check will be carried out at 4 months if an argon plasma coagulation was performed during the previous check, with a third and last argon plasma coagulation if an anastomosis of more than 1.5 cm persists. The number of procedures will therefore be a maximum of 3. A control endoscopy will be performed at one year for the final control of the anastomosis. | Procedure or surgery | APC intervention |
Primary outcome
Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms
Time frame: Day 0 (before the intervention) and Months 12 (one year after Day 0)
The percentage of excess weight loss (PEP%) will be measured according to the formula: PEP% = weight loss in kg * 100 / excess of initial weight. The initial excess weight is defined as the baseline weight - ideal weight.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Adrien STERKERS, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon plasma coagulation in people with Bariatric Surgery Candidate, run by Saint-Gregoire Private Hospital Center at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 10 Nov 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BELLEC-FAGOT (0637110376, mbellecfagot@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the percentage change (loss) in excess weight from Day 0 to Month 12 between the 2 arms (time frame: Day 0 (before the intervention) and Months 12 (one year after Day 0)). 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 10 Nov 2022.