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NCT04411823 Clinical Trial

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Gastroesophageal Reflux Clinical Trial

Official title:
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04411823
Other study ID # 19-000348
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date September 2024

Study information
Verified date February 2024
Source Mayo Clinic
Contact Elizabeth Lemke
Phone 5072663317
Email Lemke.Elizabeth@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Description:

Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients > 18 years - BMI 30 or greater kg/m2 - Participants can give a consent to the procedure - Participants have no contraindications to LSG (gastric ulceration) Exclusion Criteria: - Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture. - Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis) - Patients with hiatal hernia > 3 cm - Patients with previous esophageal or stomach surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EndoFLIP measurement
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.

Locations
Country Name City State
United States Orlando Health Orlando Florida
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Worsening or new-onset gastroesophageal reflux disease Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD. Baseline, 6 months, and 5 years
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