CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Vibrating Capsule +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03329027
NCT03329027N/ACompleted
CompareCT.gov

A Prospective, Multicenter, Randomized, Double-blind, Sham-controlled Pilot Study to Assess the Efficacy and Safety of Various Vibrating Capsule Modes

Vibrant Ltd.·interventional·Posted Nov 1, 2017·Updated Jul 3, 2024

In Brief

A clinical study evaluating Vibrating Capsule and Sham capsule for Constipation. Completed, enrolled 67 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 1, 2017
Enrollment StartNov 14, 2017
Primary CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago

Interventions

Vibrating Capsuledevice

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

Sham capsuledevice

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