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Enrolling by invitationNCT03123835Updated Dec 5, 2025

Outcome Analysis of POEM and Endoluminal Therapies

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

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Adults unable to consent
  • Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Other
    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.

    Procedure: Endoscopic Intervention

Interventions

  • ProcedureEndoscopic 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

05

What researchers measure

Primary outcomes

  1. Decrease in GERDDQ

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

    Time frame: 3-6 months

Secondary outcomes

  1. Decrease in Eckardt scoring

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

    Time frame: 30 days

06

Study locations

1 site
  • Univesity of California Davis Health System
    Sacramento, California 95817, United States
07

References and documents

Individual participant data

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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03123835
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Apr 21, 2017
Start date
Mar 2016
Primary completion
Dec 2030 (estimated)
Completion
Dec 2031 (estimated)
Last update
Dec 5, 2025

Study contacts

Mohamed R Ali, MD
principal investigator · U.C. Davis Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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