"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. (UEMREleview)
Primary Purpose
Colo-rectal Polyps
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Sponsored by
About this trial
This is an interventional treatment trial for Colo-rectal Polyps
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
"Underwater" mucosectomy
Arm Description
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Outcomes
Primary Outcome Measures
Macroscopically complete resection rate
6-month recurrence rate;
Rate of adverse events (according to the lexiconA ASGE).
Secondary Outcome Measures
Full Information
NCT ID
NCT03756636
First Posted
November 26, 2018
Last Updated
January 10, 2020
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT03756636
Brief Title
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.
Acronym
UEMREleview
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Underwater" mucosectomy
Arm Type
Other
Arm Description
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Intervention Type
Procedure
Intervention Name(s)
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Intervention Description
"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)
Primary Outcome Measure Information:
Title
Macroscopically complete resection rate
Time Frame
6 Months
Title
6-month recurrence rate;
Time Frame
6 Months
Title
Rate of adverse events (according to the lexiconA ASGE).
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.
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