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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Completed

CT.gov ID

NCT03756636

Collaborator

(none)

Enrollment

Location

Arm

5.8

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colo-rectal Polyps	Procedure: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Nov 26, 2018

Actual Study Completion Date :

Nov 26, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Other: "Underwater" mucosectomy

"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Procedure: "Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Outcome Measures

Primary Outcome Measures

Macroscopically complete resection rate [6 Months]
6-month recurrence rate; [6 Months]
Rate of adverse events (according to the lexiconA ASGE). [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT03756636

Other Study ID Numbers:

2046

First Posted:

Nov 28, 2018

Last Update Posted:

Jan 13, 2020

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Polyps

Study Results

No Results Posted as of Jan 13, 2020