NCT03329027

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Vibrant Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects will be followed continuously for at least a 2 weeks run-in period and then be randomized to either Vibrant or Sham capsules for a treatment period of 8 weeks. The first 2 weeks of treatment will be considered as a subjects' training period. Data reporting will be done on an electronic Case Report Form and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. After the run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period. Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.

Conditions

• Constipation

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-11-14
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2017-11-01
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study