ColonoscopyNCT01374945
Clearpath Miniprep Colonoscopy Study
A study testing Clearpath Lower GI in people with Colonoscopy, run by EasyGlide.
Trial summary
Use of Clearpath to facilitate successful completion of colonoscopy procedures with sub-optimal preparation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Clearpath Lower GI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patient 18-70 years
- Scheduled for colonoscopy
- Providing informed consent
Who cannot join
- Known large polyps (> 2 cm) for polypectomy
- Inflammatory Bowel Disease (IBD)
- Previous colonic surgery
- Known or suspected stricture
- Significant co morbidity
- Significant diverticular disease
- Contraindicated to receive oral Sodium Picosulfate solution
About this study
Use of Clearpath to facilitate successful completion of colonoscopy procedures with sub-optimal preparation.
- Conditions
- Colonoscopy
- Being tested
- Clearpath Lower GI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearpath Lower GIDevice
Clearpath device for cleaning of colon by irrigation and evacuation
| Study group | Role | What they receive |
|---|---|---|
| SOC preparation and colonoscopy | No intervention | Not described |
| Miniprep and Clearpath | Experimental | Not described Receives: Device: Clearpath Lower GI |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
Why it stopped: Withdrawn for business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- EasyGlide
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374945
- Sponsor's protocol ID
- EasyGlide-CL-001
- Status last verified
- Feb 2013
- First submitted
- 15 Jun 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearpath Miniprep Colonoscopy Study
- ClinicalTrials.gov ID
- NCT01374945
- Acronym / sponsor ID
- EasyGlide-CL-001
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn for business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EasyGlideIndustry (pharma, biotech, devices)
- First posted
- 16 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.
Use of Clearpath to facilitate successful completion of colonoscopy procedures with sub-optimal preparation.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC preparation and colonoscopy | No intervention | – |
| Miniprep and Clearpath | Experimental | Device: Clearpath Lower GI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient 18-70 years
- Scheduled for colonoscopy
- Providing informed consent
Key exclusion criteria (7 listed)
- Known large polyps (> 2 cm) for polypectomy
- Inflammatory Bowel Disease (IBD)
- Previous colonic surgery
- Known or suspected stricture
- Significant co morbidity
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 |
|---|---|---|
| Clearpath Lower GIClearpath device for cleaning of colon by irrigation and evacuation | Device | Miniprep and Clearpath |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clearpath Lower GI in people with Colonoscopy, run by EasyGlide.
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 7 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: withdrawn, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 27 Feb 2013.