A Study to Understand the Changes in Gastric Emptying in Response to the Endoscopic Sleeve Gastroplasty (ESG)

Overview

About this study

This study is being done to understand the short and long term changes in gastric emptying in response to the endoscopic sleeve gastroplasty (ESG).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

The following are the inclusion criteria for the main study.

Subject population Adults participating in the MERIT trial

  1. Age 21-65
  2. BMI = 30 and = 40 kg/m²
  3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
  4. History of failure with non-surgical weight-loss methods
  5. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing diet counseling and undergoing adjustment procedure
  6. Residing within a reasonable distance from the investigator’s office and able to travel to the investigator to complete all routine follow- up visits
  7. Ability to give informed consent
  8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

Exclusion Criteria: 

  1. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
  2. Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
  3. Prior open or laparoscopic bariatric surgery.
  4. Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
  5. Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett’s esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease.
  6. 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 atresias or stenoses.
  7. A gastric mass or gastric polyps > 1 cm in size.
  8. A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
  9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
  10. Achalasia or any other severe esophageal motility disorder
  11. Severe coagulopathy.
  12. Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C >= 8.5.
  13. Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
  14. Chronic abdominal pain
  15. Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
  16. Hepatic insufficiency or cirrhosis
  17. Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
  18. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
  19. Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
  20. Patients receiving daily prescribed treatment with high dose aspirin (> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
  21. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
  22. Patients who are pregnant or breast-feeding.
  23. 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
  24. Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
  25. Subjects who are taking corticosteroids, immunosuppressants, and narcotics
  26. Subjects who are taking diet pills
  27. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
  28. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
  29. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
  30. Specific diagnosed genetic disorder such as Prader Willi syndrome.
  31. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
  32. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Closed for enrollment

Contact information:

Erik Hyland B.S.

(507) 284-4723

Hyland.Erik@mayo.edu

More information

Publications

Publications are currently not available
.

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