Polyps of ColonNCT03467451
Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage
An observational study of Polyps of Colon, run by Hôpital Edouard Herriot.
Trial summary
This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Polyps of Colon
- What is being tested?
- Endoscopic Mucosectomy
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Jan 2018
- Phase
- Observational
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Both male and female over 18 years old with other rectal or colic résections from 10 to 30 mm into the past
Who may be able to join
- Age over 18 years old
- Other rectal or colic résections from 10 to 30 mm into the past
Who cannot join
- Colitis, Crohn Disease or Ulcerative Colitis
- Intense fibrosis under the lesion
About this study
Official title: Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage of the Tip of the Loop
This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams
- Conditions
- Polyps of Colon
- Being tested
- Endoscopic Mucosectomy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic MucosectomyProcedure or surgery
Endoscopic Mucosectomy with anchorage of the tip of the loop
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jul 2015
- Primary completion1 Jul 2016
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyps of ColonStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Société Française d'Endoscopie Digestive
- Investigators
- Mathieu Pioche, Principal investigator, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467451
- Sponsor's protocol ID
- Mucosectomy with anchorage
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage of the Tip of the Loop
- ClinicalTrials.gov ID
- NCT03467451
- Acronym / sponsor ID
- Mucosectomy with anchorage
- Conditions
- Polyps of Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 16 Mar 2018 (actual)
- 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.
This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Both male and female over 18 years old with other rectal or colic résections from 10 to 30 mm into the past
Key inclusion criteria (2 listed)
- Age over 18 years old
- Other rectal or colic résections from 10 to 30 mm into the past
Key exclusion criteria (2 listed)
- Colitis, Crohn Disease or Ulcerative Colitis
- Intense fibrosis under the lesion
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 |
|---|---|---|
| Endoscopic MucosectomyEndoscopic Mucosectomy with anchorage of the tip of the loop | Procedure or surgery | – |
Primary outcome
Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions
Time frame: One year
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 19 Mar 2018.
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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.
Mathieu Pioche principal investigator
Hôpital Edouard Herriot
Questions about this trial
What is this clinical trial studying?
An observational study of Polyps of Colon, run by Hôpital Edouard Herriot.
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 2 inclusion and 2 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 19 Mar 2018. 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 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?
Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions (time frame: One year). 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 19 Mar 2018.