Outcome Analysis of POEM and Endoluminal Therapies

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03123835
• Other study ID #: 676956
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2031

Study information

• Verified date: October 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia
• Fistula
• Gastric Fistula
• Gastric Nec
• Marginal Ulcer
• Peptic Ulcer
• Stenoses
• Weight Gain
• Weight Gain After Primary Weight Loss Surgery
• Weight Loss

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Univesity of California Davis Health System	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in GERDDQ	Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)	3-6 months
Secondary	Decrease in Eckardt scoring	Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)	30 days