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Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home Environment

NCT02895516 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-01-13

No results posted yet for this study

Summary

The study is a prospective, open-label, single-arm study, to evaluate the ease of use, tolerability, efficacy and safety of the Vibrant Capsule administered in the home environment.

One arm will be assessed: Vibrant Capsule administered twice a week.

Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks.

During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation.

After 14 days the patients will return and eligibility will be re-assessed. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period.

Conditions

Interventions

DEVICE

Vibrating capsule

Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week)

Sponsors & Collaborators

  • Vibrant Ltd.

    lead INDUSTRY

Principal Investigators

  • Ashok Tuteja, MD · University of Utah Healthcare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-04-30
Completion
2017-05-31

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 NCT02895516 on ClinicalTrials.gov