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A Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

NCT03329027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

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 pilot study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation.

Three arms that assessed:

* Vibrant Capsule with vibrating mode 1 administered 5 times per week
* Vibrant Capsule with vibrating mode 2 administered 5 times per week
* Sham Capsule administered 5 times per week

Conditions

Interventions

DEVICE

Vibrating Capsule

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

DEVICE

Sham capsule

Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)

Sponsors & Collaborators

  • Vibrant Ltd.

    lead INDUSTRY

Principal Investigators

  • Tal Malina, B.SC MBA · Vibrant Gastro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2018-03-30
Completion
2018-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03329027 on ClinicalTrials.gov