New hope: Stomach-Stitching procedure aims to cut obesity risks in endometrial cancer survivors
NCT ID NCT07397624
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centro di Riferimento Oncologico (CRO) - IRCCS Aviano
RECRUITINGAviano, Pordenone, 33081, Italy
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Fondazione Policlinico Universitario Campus Bio-Medico
NOT_YET_RECRUITINGRoma, Roma, Italy
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