Outcome Analysis of POEM and Endoluminal Therapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Intervention.
- Who it may be relevant to
- Registry conditions: Achalasia, Gastric Fistula, Weight Gain After Primary Weight Loss Surgery, Marginal Ulcer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms
Overview
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.
Interventions
- 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.
Primary outcome measures
- Decrease in GERDDQ [Time frame: 3-6 months]
Secondary outcome measures (1)
- Decrease in Eckardt scoring [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Univesity of California Davis Health System — Sacramento
Identifiers
NCT: NCT03123835 · 676956