NCT02637713

Brief Summary

Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
4 years until next milestone

Results Posted

Study results publicly available

May 8, 2023

Completed
Last Updated

January 23, 2024

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

November 16, 2015

Results QC Date

April 13, 2023

Last Update Submit

January 2, 2024

Conditions

GERDMorbid Obesity

Keywords

GERDsleeve gastrectomyrefluxmorbidly obese

Outcome Measures

Primary Outcomes (6)

  • Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score

    RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

    6 months

  • Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score

    RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

    12 months

  • Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score

    RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

    24 months

  • Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score

    GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

    6 months

  • Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score

    GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

    12 months

  • Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score

    GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

    24 months

Secondary Outcomes (11)

  • Esophageal pH Levels

    Baseline

  • Esophageal pH Levels

    6 months

  • Esophageal pH Levels

    12 months

  • Use of Anti-reflux Medication

    Baseline

  • Cessation or Decreased Use of Anti-reflux Medication

    6 months

  • +6 more secondary outcomes

Study Arms (1)

Radiofrequency Energy to the Lower Esophageal Sphincter (LES)

EXPERIMENTAL

All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms.

Device: StrettaProcedure: Radiofrequency (RF) Energy to the LES (Stretta Procedure)

Interventions

StrettaDEVICE

Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.

Radiofrequency Energy to the Lower Esophageal Sphincter (LES)
Radiofrequency (RF) Energy to the LES (Stretta Procedure)PROCEDURE

The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.

Radiofrequency Energy to the Lower Esophageal Sphincter (LES)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
  • On a PPI with GERD-related symptoms
  • On a PPI but like to discontinue them

You may not qualify if:

  • Age \<18 or \> 80
  • History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.
  • Unable or unwilling to consent for an invasive procedure.
  • History of intestinal leak after surgery.
  • History of revisional bariatric surgery
  • Significant sleeve abnormalities such and twist or large fundus
  • Hiatal hernia(\>2cm)
  • Pregnancy
  • Inability to comply with study protocols and procedures
  • Esophageal stricture, Eosinophilic Esophagitis or Achalasia
  • Prior esophageal surgery or therapy for Barrett's Esophagus
  • Grades 3 or 4 esophagitis
  • Gastric or esophageal varices
  • History of obstruction of the small bowel or inflammatory bowel disease
  • Pacemaker or implanted cardiac defibrillator
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Health System

Cleveland, Ohio, 44119, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann-Texas Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxObesity, Morbid

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Erin Moran-Atkin
Organization
Montefiore Medical Center
emoran2@montefiore.org
718-920-4800

Study Officials

  • Erin Moran-Atkin, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

December 22, 2015

Study Start

March 1, 2016

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 23, 2024

Results First Posted

May 8, 2023

Record last verified: 2023-12

Locations

US(13)