Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals

Chronic Idiopathic Constipation Clinical Trial

Official title:

Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030756
• Other study ID #: Vibrant-14-MS-CTIL
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: November 5, 2017
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2017
• Source: Vibrant Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged 18 years and older.

2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).

3. Patients with more than 1 bowel movement/2 weeks and < 3 bowel movement/week.

4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are <50 years old and without alarming signs and symptoms

5. Patient signed ICF

6. For women with childbearing potential, adequate contraception

Exclusion Criteria:

1. History of complicated/obstructive diverticular disease

2. History of intestinal or colonic obstruction.

3. History of significant GI disorder.

4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids

5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.

6. Presence of pacemaker.

7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

8. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.

9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)

11. Participation in another clinical study in the last 4 months prior to screening.

12. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.

13. Women who are pregnant or lactating.

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Device:
• vibrating capsule
patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
• sham non-vibrating capsule
patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].

Locations

Country	Name	City	State
Israel	Bat-Yamon	Bat Yam
Israel	Degani center Clalit MC	Hadera
Israel	Expert clinic Clalit MC	Herzliya
Israel	Talpiot clinic Clalit MC	Jerusalem
Israel	Zvoulon MC Clalit MC	Kiryat Bialik
Israel	100 Tower	Tel Aviv
Israel	Souraski Medical Center	Tel Aviv
United States	Albuquerque Neuroscience	Albuquerque	New Mexico
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Georgia Regents University	Augusta	Georgia
United States	Mgh Boston	Boston	Massachusetts
United States	MGG Group Co., Inc., Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	Huoston Methodist Hosptial	Houston	Texas
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	NYU Langone Medical Center	New York	New York
United States	Temple University School of Medicine	Philadelphia	Pennsylvania
United States	CTRS LLC	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Vibrant Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of bowel movements	change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups	3 months