An interventional study of Endoscopic Intervention in Achalasia, Gastric Fistula and Weight Gain After Primary Weight Loss Surgery, sponsored by University of California, Davis. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.
Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.
Exclusion Criteria:
Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples.
Procedure: Endoscopic Intervention
After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.
Also known as: Endoluminal Therapies, POEM, Endoscopic Revision
Decrease in GERDDQ
Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)
Time frame: 3-6 months
Decrease in Eckardt scoring
Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)
Time frame: 30 days
Plan to share: No — de-identified data will be maintained until study closure. Statistical summary of data will be published with any journal articles submitted for review/approval.
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University of California, Davis