HealthyPhase 1RD-400NCT01370759
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement
A Phase 1 study testing Cleaning capsule in people with Healthy, run by Medtronic - MITG at 1 site in Israel.
Trial summary
The purpose of this study is to demonstrate feasibility of enhancing colon cleansing. Read more about this study
- Who is it for?
- Ages 23 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cleaning capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Apr 2014
- Phase
- Phase 1
- 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 23 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject's age is between 23-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form
Who cannot join
- Contraindication to capsule endoscopy
- Contraindication or allergy to any of the products and materials used for bowel preparation
- Subject is not able to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study
The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.
Read the detailed description
To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.
The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.
- Conditions
- Healthy
- Being tested
- Cleaning capsule
- Keywords
- bowel prep, PillCam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleaning capsuleOther
Also called Active cleaning capsules
Capsules containing the tested materials aimed to improve colon cleansing
| Study group | Role | What they receive |
|---|---|---|
| Colon-targeted cleaning capsule | Experimental | Not described Receives: Other: Cleaning capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleansing grading
Measured: within 10 days
Secondary outcomes (2)
Distribution of time
Measured: within 10 days
GI tract segment of capsule disintegration
Measured: within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Terminated due to sponsor desicioun
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Gralnek, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370759
- Sponsor's protocol ID
- CTIL - RD-400
- Acronym
- RD-400
- Status last verified
- Apr 2014
- First submitted
- 9 Jun 2011
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flocculation-Adsorption System for Colon Cleansing Enhancement: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01370759
- Acronym / sponsor ID
- RD-400 / CTIL - RD-400
- Conditions
- Healthy
- Keywords
- bowel prep, PillCam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to sponsor desicioun
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 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 purpose of this study is to demonstrate feasibility of enhancing colon cleansing.
Detailed description
To ensure the success of a PillCamTM Colon examination, as standard practice, patients are requested to adhere to a bowel preparation procedure.
The study is designed to evaluate the performance and contribution of a flocculation-adsorption system to colon cleansing.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon-targeted cleaning capsule | Experimental | Other: Cleaning capsule |
Who may qualify
- Ages
- 23 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject's age is between 23-75 years.
- Subject is healthy.
- Subject agrees to sign the Informed Consent Form
Key exclusion criteria (3 listed)
- Contraindication to capsule endoscopy
- Contraindication or allergy to any of the products and materials used for bowel preparation
- Subject is not able to provide written informed consent
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 |
|---|---|---|
| Cleaning capsuleAlso: Active cleaning capsulesCapsules containing the tested materials aimed to improve colon cleansing | Other | Colon-targeted cleaning capsule |
Primary outcome
Cleansing grading
Time frame: within 10 days
2 secondary outcomes
Distribution of time
Time frame: within 10 days
GI tract segment of capsule disintegration
Time frame: within 10 days
Results and safety
The study was stopped early (reason given: Terminated due to sponsor desicioun). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Ian Gralnek, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cleaning capsule in people with Healthy, run by Medtronic - MITG at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to sponsor desicioun). Results are not available in the source record.
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?
Cleansing grading (time frame: within 10 days). 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 31 Jul 2019.