Colo-rectal PolypsUEMREleviewNCT03756636
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.
A study testing "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) in people with Colo-rectal Polyps, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract. Before the procedure each patient, a normal endoscopic procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Polyps
- What is being tested?
- "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 26 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- Signing of informed consent.
- Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
- Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.
Who cannot join
- Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
- Pregnancy or breastfeeding
- ASA> 3
- Unstable personality or unable to adhere to the protocol procedures.
- Inability to provide informed consent.
- Injury not reachable endoscopically.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, 20089
About this study
Official title: "Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study
All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.
Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.
Read more
Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".
A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure
- Conditions
- Colo-rectal Polyps
- Being tested
- "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)Procedure or surgery
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
| Study group | Role | What they receive |
|---|---|---|
| "Underwater" mucosectomy | Other | "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) Receives: Procedure: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macroscopically complete resection rate
Measured: 6 Months
6-month recurrence rate;
Measured: 6 Months
Rate of adverse events (according to the lexiconA ASGE).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Jun 2018
- Primary completion26 Nov 2018
- Study completion26 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal PolypsStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756636
- Sponsor's protocol ID
- 2046
- Acronym
- UEMREleview
- Status last verified
- Sep 2019
- First submitted
- 26 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study
- ClinicalTrials.gov ID
- NCT03756636
- Acronym / sponsor ID
- UEMREleview / 2046
- Conditions
- Colo-rectal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 26 Nov 2018 (actual)
- First posted
- 28 Nov 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.
All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.
Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.
Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".
A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Underwater" mucosectomy | Other | Procedure: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years.
- Signing of informed consent.
- Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
- Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.
Key exclusion criteria (6 listed)
- Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
- Pregnancy or breastfeeding
- ASA> 3
- Unstable personality or unable to adhere to the protocol procedures.
- Inability to provide 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 |
|---|---|---|
| "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) | Procedure or surgery | "Underwater" mucosectomy |
Primary outcome
Macroscopically complete resection rate
Time frame: 6 Months
6-month recurrence rate;
Time frame: 6 Months
Rate of adverse events (according to the lexiconA ASGE).
Time frame: 6 Months
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 13 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) in people with Colo-rectal Polyps, run by Istituto Clinico Humanitas at 1 site in Italy.
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 6 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 13 Jan 2020. 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 Italy. 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?
Macroscopically complete resection rate (time frame: 6 Months). The study lists 3 primary outcomes in all. 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 13 Jan 2020.