Outcome Analysis of POEM and Endoluminal Therapies

University of California (UC) Davis

Status: Invitation-only

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

Treatments: Procedure: Endoscopic Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03123835

676956

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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
• Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Treatment

Other group

Description:

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.

Treatment:

Procedure: Endoscopic Intervention