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

Colo-rectal Polyps Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756636
• Other study ID #: 2046
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: November 26, 2018

Study information

• Verified date: September 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colo-rectal Polyps
• Polyps
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macroscopically complete resection rate		6 Months
Primary	6-month recurrence rate;		6 Months
Primary	Rate of adverse events (according to the lexiconA ASGE).		6 Months