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

NCT03329027 | Completed Results FDA Device

• 1 other identifier: 300CLD
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 4

Brief 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

Constipation

Outcome Measures

Primary Outcomes (2)

• CSBM1- an Increase of at Least One Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment

  CSBM1 success rate, defined as an increase from the base line of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment

  8 weeks

• CSBM2- an Increase of at Least Two Weekly Complete Spontaneous Bowel Movement (CSBM) During at Least 6 of the 8 Weeks of Treatment

  CSBM2 success rate, defined as an increase from the base line of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.

  6-8 weeks

Secondary Outcomes (1)

• SBM 1- Success Rate, Defined as as an Increase From the Base Line of at Least One Weekly Spontaneous Bowel Movement (SBM) During at Least 6 of the 8 Weeks of Treatment.

  6-8 weeks

Study Arms (3)

Active Comparator-Vibrating Mode 1

EXPERIMENTAL

Patients will receive vibrating capsule Vibrating Mode 1 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions

Device: Vibrating Capsule

Active Comparator-Vibrating Mode 2

EXPERIMENTAL

Patients will receive vibrating capsule Vibrating Mode 2 for 8 weeks of treatment (5 capsules/week). Active Mode 1 and Active Mode 2 differ in their vibration sessions

Device: Vibrating Capsule

Sham Comparator

SHAM COMPARATOR

Patients will receive sham capsule for 8 weeks of treatment (5 capsules/week). The Sham capsule is visually similar to the active capsules (Active Mode 1 and Active Mode 2, which differ in their vibration sessions) but without the active components.

Device: Sham capsule

Interventions

Vibrating Capsule DEVICE

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

Active Comparator-Vibrating Mode 1; Active Comparator-Vibrating Mode 2

Sham capsule DEVICE

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

Sham Comparator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 22 years and older
• Subjects with Chronic Idiopathic Constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies
• Subjects with an average of \<3 Spontaneous Bowel Movements per week and ≥1 Spontaneous Bowel Movements per week
• Normal colonoscopy performed within 10 years prior to study participation, unless the subjects are \<50 years old and without alarm signs and/or symptoms
• Subject signed the Informed Consent Form
• Female subjects must have a negative pregnancy test

You may not qualify if:

• History of complicated/obstructive diverticular disease
• History of intestinal or colonic obstruction, or suspected intestinal obstruction.
• History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy
• History of gastroparesis
• Use of any of the following medications:
• Medications that may affect intestinal motility, prokinetics, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
• With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.
• Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease.
• Presence of cardiac pacemaker or gastric electrical stimulator.
• History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
• Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
• History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia
• Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
• Subjects with pelvic floor dysfunction/defecatory disorder
• Participation in another clinical study within one month prior to screening.

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (4)

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, 87109, United States

Location

Great Lakes Medical Research

Willoughby, Ohio, 44094, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical trials manager
• Organization: Vibrantgastro

service@vibrantgastro.com

046663322

Study Officials

• Tal Malina, B.SC MBA

  Vibrant Gastro

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: November 14, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)