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A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

NCT05192538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-16

No results posted yet for this study

Summary

The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. In the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.Thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. The secondary outcomes included improvement in esophageal 24-hr pH monitoring, improvement in quality of life questionnaires and safety. Patient follow-up assessments were completed at 7 and 14 days post treatment.

Conditions

  • GERD
  • Reflux Esophagitis

Interventions

DEVICE

Endoscopic endoloop pre-test treatment

A novel endoloop was inserted into the gastric cardia by forceps through the single-channel endoscopy. After adjustment of the endoloop's location and angle, it was anchored onto the edge of the gastric cardia with clip and another 1 or 2 clips were inserted to hold the opposite side of endoloop at about 1/2 circumference. Then the hook was connected with the endoloop, which was tighted by slight pulling together of all the clips.

Sponsors & Collaborators

  • Beijing 302 Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Liu, Pro. · Beijing 302 Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2022-04-01
Completion
2022-05-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05192538 on ClinicalTrials.gov