Outcome Analysis of POEM and Endoluminal Therapies

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT03123835
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Mar 31, 2016
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Decrease in GERDDQ [ Time Frame: 3-6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Univesity of California Davis Health SystemSacramentoCalifornia95817-

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Univesity of California Davis Health System· Sacramento, CA

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