NCT02895516

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

A Prospective, Open-label, Single-arm Study to Assess the Ease of Use, Tolerability, Efficacy and Safety of the Vibrant Capsule Administered in the Home Environment.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

• Constipation

Interventions

Type	Name	Description
DEVICE	Vibrating capsule	Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week)

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2016-09-09
• Last updated: 2017-01-13

Locations

1 site across 1 country: United States