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

NCT03756636 | Completed

• 1 other identifier: 2046
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Colo-rectal Polyps

Outcome Measures

Primary Outcomes (3)

• Macroscopically complete resection rate

  6 Months

• 6-month recurrence rate;

  6 Months

• Rate of adverse events (according to the lexiconA ASGE).

  6 Months

Study Arms (1)

"Underwater" mucosectomy

OTHER

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

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

Interventions

"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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: June 1, 2018
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: January 13, 2020

Record last verified: 2019-09

Locations

IT (1)