NCT03756636

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)	"Underwater" mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-11-26
• Completion: 2018-11-26
• First posted: 2018-11-28
• Last updated: 2020-01-13

Locations

1 site across 1 country: Italy