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A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

NCT03031301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-07-03

Study results available
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Summary

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.

Two arms will be assessed:

* Vibrant Capsule administered 5 times per week
* Sham Capsule administered 5 times per week

Conditions

Interventions

DEVICE

Vibrant capsule

One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.

DEVICE

Sham capsule

One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.

Sponsors & Collaborators

  • Vibrant Ltd.

    lead INDUSTRY

Principal Investigators

  • Dvora Darky · Vibrant Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2018-07-30
Completion
2018-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03031301 on ClinicalTrials.gov