Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass. (APOLLO)

September 29, 2025 updated by: University Hospital, Montpellier

Medico-economic Evaluation of the Management of Weight Regain After Gastric Bypass by Gastrointestinal Narrowing of Jejunal Anastomosis by Endoscopic Suturing: Apollo Endosurgery OverStitch Technical

Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nowadays morbid obesity (BMI ≥ 40kg/m²) is a major problem of public health in industrialized countries. About 500 000 patients would be affected by this disease in France in 2009. Prevalence of the morbid obesity raised from 0.3 % (± 0.1 %) of the population in 1997 to 1.1 % (± 0.1 %) in 2009 (Extrapolation of the data ObEpi on 2009 to the French population) (1). For this type of patient, the only long-term effective treatment recognized by the scientists is the bariatric surgery. (2-4) Roux and Y Gastric Bypass (GBP) is a consensual procedure, that has been described in the sixties, in this indication (approximately 11000 GBP performed in FRance in 2012 (5,6). This operation consists on the creation of a proximal gastric pouch (50 cc). A Roux and Y intestinal loop will be added to create a malabsorptive part. 60 to 80 % of excess weight loss described in the literature in the long-terms. Furthermore, improvement or remission of T2DM, sleep apnea syndrome, arterial hyperpressure, dyslipidemia) are emphasized in many trials (5, 7). However 15 to 20 % of the handled patients present a weight regain 5 years post surgery potentially explained by the dilation of the gastric pouch or the gastro jejunal anastomosis and thus a decrease of the restrictive effect. (8-11) To palliate this complication two solutions are described. (12-15; 19) The first one consists in a recalibration of the gastric poouch by surgical approachy. In this case, a ring of silicone or polypropylene can be positioned around the gastric pocket. Other possible solution is to redo a new gastrojejunostomy with a smaller size, by surgical access (laparotomy or laparoscopy). These interventions are very delicate because of important peritoneal adhesions and present a rate of significant morbidity especially if they are performed under laparotomy. The pure medical care does not allow long-term results stable. ²² A therapeutic dead end is reported often for this type of patient. A new possibility was recently described. (17-18) A recalibration can be realized by sutures performed under endoscopic approach at the level of the gastro jejunal anastomosis or from the gastric pouch by the APOLLO Endosurgery OverStitch. The digestive surgery by endoscopic way is rapidly expanding. The first results seem to be promising (resumed the weight loss) but owe to be estimated in a randomized study comparing this new process with the medical conventional treatment. A single-blind, randomized, forward-looking study, multicenter, comparative between two parallel groups of patients presenting a weight regain after GBP was thus organized. The main objective is to estimate the efficiency of the APOLLO Endosurgery OverStitch technique versus the non-interventional strategy. The secondary endpoints is to study the morbidity of the procedure, the evolution of quality of life of the patients, the medical economic impact of the innovation in 24 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Louis Mourier Hospital
      • Lille, France
        • Lille Hospital
      • Montpellier, France, 34000
        • Montpellier Hospital
      • Nice, France, 06000
        • Nice Hospital
      • Paris, France, 75015
        • HEGP Hospital
      • Strasbourg, France, 67000
        • Strasbourg hospital
      • Villeurbanne, France, 69000
        • Villeurbanne clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age > 18 years
  • Surgical criteria: patient with bariatric surgery by gastric bypass since, at least, 24 months

  • Clinics criteria of weight regain or treatment failure:

    • Patient with weight regain> 5kg / m²
    • Patient with EWL (excess weight loss) <25% after 2 years of treatment.
  • Loss of early satiety (interrogation)
  • Patient with a compatible psychological and cognitive status with the study,
  • Patient agreeing to follow the procedures of the study and can participate at the follow-up study during 2 years
  • Subject with no rights from the national health insurance programme
  • Consent form signed

Exclusion criteria:

  • Pregnancy (plasma assay of beta-HCG positive)
  • Presence of cardiovascular, neurological, psychiatric, endocrine, renal, gastrointestinal or tumor comorbidities making irrelevant patient participation in the judgment of the investigator
  • Patient participating in another clinical study or participated in another study within the last 30 days or for which the annual compensation received exceeds € 4,500
  • Patient with a contre-indication to the achievement of surgery (fistula, ulceration, ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm with Apollo Endosurgery OverStitch technical
Device: Regular endoscopy + endogastric suturing
Patients will get the usual endoscopy used for diagnosis. In addition, they will receive an endoscopic surgery using the APOLLO Endosuregery technique. The Apollo Endosurgery OverStitch is an endoscopic equipment which involves the suturing by endogastric way to decrease the size of the anastomosis gastrojujenal or gastric pouch
Placebo Comparator: Arm without Apollo Endosurgery OverStitch technical
Diagnostic test: Regular endoscopy
Patients will get the usual endoscopy used for diagnosis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight loss assessment of Apollo Endosurgery OverStitch technical
Time Frame: At 12 and 24 months after surgery
The main objective is to compare the efficacy of endoscopic surgery Apollo Endosurgery OverStitch technical than the conventional non-interventional strategy in patients with weight regain after gastric bypass.Moreover, all of these patients will also benefit from the medical-nutritional usual care.
At 12 and 24 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of both strategies on tolerance (adverse events and serious adverse events)
Time Frame: At 12 months after Baseline and at each visit
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on tolerance and safety related to obesity.
At 12 months after Baseline and at each visit
Comparison of both strategies on comorbidities
Time Frame: At 12 months after Baseline and at each visit
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on comorbidities related to obesity (type 2 diabetes, arterial hypertension, sleep apnea syndrome, ...).
At 12 months after Baseline and at each visit
Comparison of both strategies on quality of life
Time Frame: At 12 months after Baseline and at each visit
The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on quality of life.
At 12 months after Baseline and at each visit
Comparison of both strategies on medico-economic impact (drugs fees, medical consultation fees..)
Time Frame: At 12 months after Baseline and at each visit

The secondary objectives of this study were to compare in real life these both strategies of the management of weight regain after gastric bypass on medico-economic impact of innovation.

Moreover, a cost-effectiveness analysis will be performed at the end of this study.
At 12 months after Baseline and at each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 50372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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