Underwater Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.

Study Overview
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Brief Summary
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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

Official Title
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Underwater Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study

Conditions
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Colo-rectal Polyps

Intervention / Treatment
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* Procedure: Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Underwater mucosectomy<br>Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM) | Procedure: Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)<br>* Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macroscopically complete resection rate |  | 6 Months | 
| 6-month recurrence rate; |  | 6 Months | 
| Rate of adverse events (according to the lexiconA ASGE). |  | 6 Months |