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Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

NCT03879239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2024-08-09

Study results available
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Summary

The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DEVICE

Vibrating capsule

Vibrating Capsule administered 5 times per week

Sponsors & Collaborators

  • Vibrant Ltd.

    lead INDUSTRY

Principal Investigators

  • Tal Malina, MBA · Vibrant Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2021-07-16
Completion
2022-01-05
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 NCT03879239 on ClinicalTrials.gov