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Outcome Analysis of POEM and Endoluminal Therapies

Primary Purpose

Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscopic Intervention
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achalasia focused on measuring Achalasia, Fistula, Obesity, POEM, GERD, endoscopic, treatments, post bariatric surger weight gain, endoluminal, Bariatric Surgery, Barretts

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Univesity of California Davis Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2016
Last Updated
October 12, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03123835
Brief Title
Outcome Analysis of POEM and Endoluminal Therapies
Official Title
Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Intervention
Other Intervention Name(s)
Endoluminal Therapies, POEM, Endoscopic Revision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decrease in GERDDQ
Description
Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)
Time Frame
3-6 months
Secondary Outcome Measure Information:
Title
Decrease in Eckardt scoring
Description
Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R Ali, MD
Organizational Affiliation
U.C. Davis Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univesity of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
de-identified data will be maintained until study closure. Statistical summary of data will be published with any journal articles submitted for review/approval.

Learn more about this trial

Outcome Analysis of POEM and Endoluminal Therapies

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