Outcome Analysis of POEM and Endoluminal Therapies

NCT03123835 | Enrolling By Invitation

• 1 other identifier: 676956
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Conditions

Achalasia; Gastric Fistula; Weight Gain After Primary Weight Loss Surgery; Marginal Ulcer; Stenoses; Gastric Nec

Keywords

Achalasia; Fistula; Obesity; POEM; GERD; endoscopic; treatments; post bariatric surger weight gain; endoluminal; Bariatric Surgery; Barretts

Outcome Measures

Primary Outcomes (1)

• Decrease in GERDDQ

  Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)

  3-6 months

Secondary Outcomes (1)

• Decrease in Eckardt scoring

  30 days

Study Arms (1)

Treatment

OTHER

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

Interventions

Endoscopic Intervention PROCEDURE

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

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female patients 18-80 years of age
• Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
• Gastrointestinal Reflux Disease
• Achalasia
• Barrett's Esophagus
• Post Bariatric Surgery conditions
• Other gastrointestinal and postsurgical disorders.

You may not qualify if:

• Adults unable to consent

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Univesity of California Davis Health System

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Esophageal Achalasia; Gastric Fistula; Peptic Ulcer; Constriction, Pathologic; Fistula; Obesity; Gastroesophageal Reflux

Interventions

nephronectin

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Digestive System Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Mohamed R Ali, MD

  U.C. Davis Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 21, 2017
• Study Start: March 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)