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CompletedNCT02030756Updated Nov 7, 2017

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

An interventional study of vibrating capsule and sham non-vibrating capsule in Chronic Idiopathic Constipation, sponsored by Vibrant Ltd.. Completed at 18 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Vibrant Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Idiopathic Constipation

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Keywords

  • constipation
03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 144 is above the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Vibrant Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
  1. Participation in another clinical study in the last 4 months prior to screening.
  1. 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.
  1. Women who are pregnant or lactating.

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
144 participants (actual)

Study arms

  • Active comparator
    Vibrating capsule

    patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

    Device: vibrating capsule

  • Sham comparator
    sham non-vibrating capsule

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

    Device: sham non-vibrating capsule

Interventions

  • Devicevibrating capsule

    patients will receive vibrating capsule for 8 weeks of treatment \[1 every 3 days (+/- 1 day)\].

  • Devicesham non-vibrating capsule

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

07

Study locations

18 sites
  • Borland-Groover Clinic
    Jacksonville, Florida 32256, United States
  • Georgia Regents University
    Augusta, Georgia 30912, United States
  • MGG Group Co., Inc., Chevy Chase Clinical Research
    Chevy Chase, Maryland 20815, United States
  • Mgh Boston
    Boston, Massachusetts 02114, United States
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109, United States
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
  • Albuquerque Neuroscience
    Albuquerque, New Mexico 87109, United States
  • NYU Langone Medical Center
    New York, New York 10016, United States
  • Temple University School of Medicine
    Philadelphia, Pennsylvania 19140, United States
  • CTRS LLC
    Pittsburgh, Pennsylvania 15206, United States
  • Huoston Methodist Hosptial
    Houston, Texas 77030, United States
  • 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, Israel
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02030756
Lead sponsor
Vibrant Ltd.
Responsible party
Sponsor
First posted
Jan 8, 2014
Start date
Jul 2014
Primary completion
Jan 2016
Completion
Feb 2016
Last update
Nov 7, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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