Outcome Analysis of POEM and Endoluminal Therapies

NCT ID: NCT03123835

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2031-12-31

Brief Summary

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

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: OTHER

Endoscopic Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Endoluminal Therapies, POEM, Endoscopic Revision

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Adults unable to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed R Ali, MD

Role: PRINCIPAL_INVESTIGATOR

U.C. Davis Medical Center

Locations

Univesity of California Davis Health System

Sacramento, California, United States

Countries

United States

Other Identifiers

676956

Identifier Type: -

Identifier Source: org_study_id