Pilot Study of Endoscopic Sleeve Gastroplasty for Obese Patients With Heart Failure and Preserved Ejection Fraction

August 27, 2026 updated by: Michael Farkouh, Cedars-Sinai Medical Center

Pilot Clinical Study Evaluating Endoscopic Sleeve Gastroplasty (ESG) for Obese Patients With Heart Failure With Preserved Ejection Fraction

This is a small research study to see whether losing weight with a minimally invasive weight-loss procedure called endoscopic sleeve gastroplasty (ESG) can help improve symptoms of a type of heart failure called HFpEF in adults with obesity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

During the ESG procedure, a specially trained doctor uses a flexible tube passed through the mouth to place stitches inside the stomach. This makes the stomach smaller so people feel full sooner and eat less, which can help with weight loss. The procedure uses the OverStitch Endoscopic Suturing System and is performed by trained gastroenterologists or surgeons.

The study is for adults with obesity who have a BMI between 30 and 50 and have not been able to lose weight or keep it off through diet, exercise, or other non-surgical approaches.

The goal of the study is to learn whether weight loss after ESG can improve heart failure symptoms, such as shortness of breath, tiredness, and difficulty with physical activity.

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 (Estimated)

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.
20

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

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI 30-50 kg/m2
  • Stable weight within the 3-months prior to enrollment (< 5 % weight loss or gain)
  • Documented heart failure, defined by satisfying at least one of the below criteria, with left ventricular ejection fraction ≥ 45% at time of screening
  • Elevated left ventricular filling pressures
  • Elevate natriuretic peptide levels
  • Echocardiographic abnormalities consistent with HFpEF
  • Hospitalization for heart failure in prior 12 months plus ongoing treatment with diuretics
  • NYHA Functional Class II-IV
  • KCCQ-CSS score < 90
  • 6-minute walk test > 100 m
  • No hospitalizations due to HF between screening and baseline visit
  • Satisfies the indications for use and intended population as described in the IFU for Overstitch Endoscopic Suturing System
  • Is not currently taking any over the counter or prescribed weight loss supplements or any anti-obesity medications
  • Agrees not to take additional over the counter or prescribed weight loss supplements / medications during study participation
  • Medications for management of diabetes that are stable for the last 6 months, no changes to type or dose and no expected changes during study participation
  • Agrees to the follow-up requirements of the study and provides informed consent

Exclusion Criteria:

  • Patients not willing to have an ESG procedure for the treatment of weight loss
  • History of prior bariatric surgery or procedure
  • Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
  • Esophageal, gastric or duodenal malignancy
  • Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
  • Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
  • Prior surgical or endoscopic anti-reflux procedure
  • Current or planned management of Type 2 Diabetes with incretin medications
  • Inability or unwillingness to comply with protocol requirements related to visits
  • Investigator's medical judgement that the subject is not a candidate for the ESG procedure
  • MI, stroke, hospitalization for HF, unstable angina pectoris, or TIA within 30 days prior to the day of screening
  • SBP >160 mm Hg at screening
  • Planned coronary, carotid or peripheral artery revascularization
  • Any other condition judged by the investigator to be the primary cause of dyspnea
  • End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis
  • Presence or history of malignant neoplasm within 5 years prior to the day of screening Basal and squamous cell cancer and any carcinoma in-situ are allowed
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
  • Participation in any clinical trial of an approved or non-approved device for the treatment of HF or obesity within 30 days before screening
  • Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator
  • Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Endoscopic sleeve gastroplasty (ESG)
All participants will undergo endoscopic sleeve gastroplasty (ESG), a minimally invasive, non-surgical weight-loss procedure. During the procedure, a flexible endoscope is passed through the mouth into the stomach. Using the OverStitch Endoscopic Suturing System, the physician places a series of sutures to reduce the stomach's volume. The reduced stomach size promotes earlier fullness during meals, helping participants decrease food intake and achieve weight loss.
Procedure: Endoscopic sleeve gastroplasty (ESG)
The endoscopic sleeve gastroplasty (ESG) is a minimally invasive, non-surgical weight-loss procedure. During the procedure, a flexible endoscope is passed through the mouth into the stomach. Using the OverStitch Endoscopic Suturing System, the physician places a series of sutures to reduce the stomach's volume.

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
To assess improvement in HFpEF symptom burden at 12 months post-ESG, as measured by change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline
Time Frame: From baseline to the end of 12 month follow up.
Score range: 0-100- Higher scores indicate better health status and lower heart failure symptom burden. Positive changes from baseline reflect improvement
From baseline to the end of 12 month follow up.
To assess percent body weight loss (TBWL) at 12 months post-ESG (%)
Time Frame: From baseline to the end of 12 months follow-up.
Percent total body weight loss (TBWL) at 12 months following ESG, calculated as the percentage change in body weight from baseline.
From baseline to the end of 12 months follow-up.

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.
Cedars-Sinai Medical Center

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 (Estimated)

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.
September 1, 2026

Primary Completion (Estimated)

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.
September 1, 2028

Study Completion (Estimated)

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.
September 1, 2028

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).
August 27, 2026

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.
August 27, 2026

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.
September 1, 2026

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.
September 1, 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.
August 27, 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.
August 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.
  • STUDY00004148

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be shared because of participant privacy considerations and limitations of the informed consent.

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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