Status:
COMPLETED
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Colo-rectal Polyps
Eligibility:
All Genders
18+ years
Phase:
NA
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. Be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03756636
Start Date
June 1 2018
End Date
November 26 2018
Last Update
January 13 2020
Active Locations (1)
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1
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089