Clinical Trials Directory

Trials / Unknown

UnknownNCT05247515

Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection

Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
304 (estimated)
Sponsor
Gabriel RAHMI · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.

Conditions

Interventions

TypeNameDescription
DEVICEEndoscopic mucosal resection with nexpowderAt the end of the EMR procedure, the patient will be randomized. In the treated group, Nexpowder will be sprayed thanks to a catheter inserted through the operating channel of the endoscope.

Timeline

Start date
2022-07-01
Primary completion
2022-08-01
Completion
2024-08-01
First posted
2022-02-21
Last updated
2022-02-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05247515. Inclusion in this directory is not an endorsement.