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New hope: Stomach-Stitching procedure aims to cut obesity risks in endometrial cancer survivors

NCT ID NCT07397624

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a less invasive weight-loss procedure called endoscopic suture gastroplasty (ESG) in 74 obese women who have had curative treatment for endometrial cancer. The goal is to see if ESG is safe and effective for helping these women lose weight, since obesity raises the risk of cancer coming back and other health problems. Participants will also follow a lifestyle program. The procedure uses a flexible tube with a camera to stitch the stomach smaller, without the need for traditional surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women with endometrial cancer scheduled for hysterectomy with a curative intent, with BMI ≥ 30 and Willingness to undergo E-ESG and lifestyle modifications program

Ages

21 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women with endometrial cancer scheduled for hysterectomy with a curative intent * Age 21-75 * BMI ≥ 30 * Willingness to undergo E-ESG and lifestyle modifications program * Willingness to comply with the substantial lifelong dietary restrictions required by the procedure * Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling * Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits * Ability to give informed consent Exclusion Criteria: * History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy) * Prior gastrointestinal surgery with sequelae, i.e., obstruction, and/or adhesive peritonitis or known abdominal adhesions * Prior open or laparoscopic bariatric surgery * Prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery * Any inflammatory disease of the gastrointestinal tract including severe (LA Grade C or D) esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease * Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresia or stenoses * Gastrointestinal stromal tumors, history of premalignant gastric lesions (advanced atrophic gastritis), history of familial and non-familial adenomatous syndromes * A gastric mass or gastric polyps \> 1 cm in size * A hiatal hernia \> 4 cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms * A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope * Achalasia or any other severe esophageal motility disorder * Severe coagulopathy * Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy * Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis, or intractable constipation * Hepatic insufficiency or cirrhosis * Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing * Active psychological issues preventing participation in a life-style modification program as determined by a psychologist * Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up * Patients who are unable or unwilling to take prescribed proton pump inhibitor medication * Patients receiving daily prescribed treatment with high dose aspirin (\> 80 mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants * Patients who are pregnant or breast-feeding * Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs * Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications * Subjects who are taking corticosteroids, immunosuppressants, and narcotics * Subjects who are taking diet pills * Symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease * Pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer * Diagnosis of autoimmune connective tissue disorder (e.g., lupus, erythematosus, scleroderma) or immunocompromised * Specific diagnosed genetic disorder such as Prader Willi syndrome * Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating * Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro di Riferimento Oncologico (CRO) - IRCCS Aviano

    RECRUITING

    Aviano, Pordenone, 33081, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    NOT_YET_RECRUITING

    Roma, Roma, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.