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Enrolling by Invitation

NCT Number: NCT03123835

Outcome Analysis of POEM and Endoluminal Therapies

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

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Key information

Conditions

Achalasia Body Weight Constriction, Pathologic Deglutition Disorders Digestive System Diseases Digestive System Fistula Duodenal Diseases Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Fistula Gastric Fistula Gastric Nec Gastroesophageal Reflux Gastrointestinal Diseases Intestinal Diseases Marginal Ulcer Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peptic Ulcer Signs and Symptoms Stenoses Stomach Diseases Weight Gain After Primary Weight Loss Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univesity of California Davis Health System

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Endoluminal Therapies, POEM, Endoscopic Revision

Primary outcomes

  1. Decrease in GERDDQ

    Time frame: 3-6 months

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

Secondary outcomes

  1. Decrease in Eckardt scoring

    Time frame: 30 days

    Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms

Important dates

Study start
2016
Primary completion
2030
Study completion
2031
First posted
Apr 21, 2017
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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