ConstipationVibrantNCT01306448
Safety Evaluation of the Vibrating Capsule
A study testing Vibrant capsule in people with Constipation, run by Vibrant Ltd. at 3 sites in Israel.
Trial summary
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Vibrant capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesIsrael
- Study dates
- Mar 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age 18-60 years
- Ability of subject to understand character and individual consequences of clinical trial
- Written informed consent must be available before enrollment in the trial
- For women with childbearing potential, adequate contraception
Who cannot join
- Patient with Diverticulosis
- Patient must not use protocol-defined prohibited medicine
- History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
- Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
- Presents of pacemakers
- History of or current eating disorder such as anorexia or bulimia or compulsory overeating.
- 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 gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia.
- Actively participating in another clinical trial
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Barzilai MC
Ashkelon
Italian Hospital
Nazeret
Tel Aviv Souraski medical Center
Tel Aviv, Israel
About this study
Official title: Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
Read the detailed description
Healthy volunteers will be followed for safety for 7 days after taking the capsule.
Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.
- Conditions
- Constipation
- Being tested
- Vibrant capsule
- Keywords
- constipation, gastro, vibrating capsule, safety
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant capsuleDevice
Also called Vibrant
vibrating capsule
| Study group | Role | What they receive |
|---|---|---|
| vibrating capsule | Experimental | Not described Receives: Device: Vibrant capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Measured: 7.5 weeks of treatment period
Secondary outcomes (2)
Change in spontaneous bowel movement per week compared to baseline
Efficacy will be assessed by increase of more than one complete spontaneous bowel movement per week during the 7.5 weeks of treatment compared to 2 weeks baseline
Measured: 9.5 weeks
Patient assessment of capsule tolerability
Comfort and tolerability will be assessed by the patient. Tolerability evaluation will include: assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life.
Measured: 7.5 weeks of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306448
- Sponsor's protocol ID
- Vibrant-09-MS-CTIL
- Acronym
- Vibrant
- Status last verified
- Dec 2014
- First submitted
- 21 Feb 2011
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
- ClinicalTrials.gov ID
- NCT01306448
- Acronym / sponsor ID
- Vibrant / Vibrant-09-MS-CTIL
- Conditions
- Constipation
- Keywords
- constipation, gastro, vibrating capsule, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
Detailed description
Healthy volunteers will be followed for safety for 7 days after taking the capsule.
Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vibrating capsule | Experimental | Device: Vibrant capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age 18-60 years
- Ability of subject to understand character and individual consequences of clinical trial
- Written informed consent must be available before enrollment in the trial
- For women with childbearing potential, adequate contraception
Key exclusion criteria (8 listed)
- Patient with Diverticulosis
- Patient must not use protocol-defined prohibited medicine
- History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave)
- Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions
- Presents of pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant capsuleAlso: Vibrantvibrating capsule | Device | vibrating capsule |
Primary outcome
Number of patients with adverse events
Time frame: 7.5 weeks of treatment period
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
2 secondary outcomes
Change in spontaneous bowel movement per week compared to baseline
Time frame: 9.5 weeks
Patient assessment of capsule tolerability
Time frame: 7.5 weeks of treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant capsule in people with Constipation, run by Vibrant Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: 7.5 weeks of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.