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Novel Endoluminal Clinical TreAtment of Reflux

NCT03090607 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-12

No results posted yet for this study

Summary

This is a prospective, multi-center, double-blind, crossover, randomized controlled trial designed to demonstrate the safety and efficacy of Aluvra for the treatment of GERD.

Conditions

  • GERD

Interventions

DEVICE

Aluvra™

Endoscopic injection of bulking agent to the lower esophageal sphincter

DRUG

Saline

Endoscopic injection of saline

Sponsors & Collaborators

  • Impleo Medical Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

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 NCT03090607 on ClinicalTrials.gov