Endoscopic Sleeve Gastroplasty for Moderate Obesity (PLICATURE)

April 29, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Endoscopic Sleeve Gastroplasty for Overweight or Moderately Obese Patients: Identification of Predictive Factors for Weight Loss

Weight loss is of paramount importance to ameliorate obesity-related complications. Endoscopic sleeve gastroplasty is a new therapeutic option to obtain significant weight reduction in obese patients. Nevertheless, a only a part of patients experience sufficient weight loss to improve comorbidities. A better understanding of mechanisms driving body weight trajectory after endoscopic sleeve gastroplasty may help patient selection and improve efficacy. The main aim of this study is to identify factors associated with weight reduction after endoscopic sleeve gastroplasty in patients with overweight or morbid obesity without indication to bariatric surgery. For this purpose, the investigators conduct a retro-prospective cohort study including patients with overweight or moderate obesity undergoing endoscopic sleeve gastroplasty between March 2017 and March 2023

Study Overview

Status

Status

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

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

The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty). The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.

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.
Observational

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.
116

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Clamart, France, 92140
        • AP-HP, Antoine Béclère Hospital, Department of Hepatology, Gastroenterology, and Nutrition

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with moderate obesity undergoing endoscopic sleeve gastroplasty

Description

Inclusion Criteria:

  • Age ≥18 years
  • Patients giving their consent for the study
  • Body mass index between 28 and 35 kg/m2 with co-morbid condition (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, non-alcoholic fatty liver disease or invalidating joint pain)
  • No weigh loss following life-style changes

Exclusion Criteria:

  • Antibiotic treatment during the three previous months
  • Patients at risk of gastric cancer requiring regular endoscopic surveillance
  • Gastric localization of Crohn disease
  • Portal hypertension
  • Severe hepatic or renal failure
  • Ongoing peptic ulcer
  • Severe associated disease
  • History of previous bariatric surgery

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Moderately obese patients
Moderately obese patients undergoing endoscopic sleeve gastroplasty
Other: OBPLUS Clinical Database : data analysis
The data processed relates to patients cared for in the Hepato-gastroenterology and nutrition department of the Antoine Béclère Hospital at the Assistance Publique - Hôpitaux de Paris (AP-HP. All of the clinical and paraclinical data are collected during the visits and entered into the OBPLUS database (database registered in the AP-HP register). These data will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication.
Other: Biological collection "Liver, bile ducts and pancreas": sample analysis
The samples (plasma, serum, saliva, stool) collected during the samples taken as part of the patient's care were the subject of a biological collection "Liver, bile ducts and pancreas". These samples will be analyzed in order to identify the predictive factors of the effectiveness of the fundo-plication.

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
Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery)
Time Frame: Before endoscopic sleeve gastroplasty
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry.
Before endoscopic sleeve gastroplasty

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
Clinical parameters at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Weight expressed in kg, percentage of total weight loss and percentage of excessed weight loss will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Basic serum lipid profile will be analysed by spectrometry as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Glycated hemoglobin expressed in % will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Insulin expressed in mUI/l will be analysed as it is systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
C peptide expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Ferritin expressed in µg/l will be analysed as it is systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
ALT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
AST levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
GGT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
ALP levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Transient elastometry expressed in kPa will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Controlled attenuation parameter expressed in dB/m will be analysed as they are systematically available in usual clinical practice.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention.
Time Frame: Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics by mass spectrometry.
Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12
Complications of endoscopic sleeve gastroplasty
Time Frame: During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12
Data on the potential complications (occurrence of perforation, bleeding, peritonitis and other infections, thrombo-embolic events and death) of endoscopic sleeve gastroplasty will be collected.
During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12

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.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
INSERM U996

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cosmin VOICAN, MD, PhD, APHP, Antoine-Béclère Hospital

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 2, 2023

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.
March 31, 2023

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.
March 31, 2023

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).
December 7, 2022

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.
February 20, 2023

First Posted (Actual)

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.
March 1, 2023

Study Record Updates

Last Update Posted (Actual)

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.
May 5, 2026

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.
April 29, 2026

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.
April 1, 2026

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.
  • APHP230192

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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