Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection (NEX-ENDOHS)

Free University of Brussels (ULB)

Status

Enrolling

Conditions

Polyps

Gastro Intestinal Bleeding

Treatments

Device: NEXPOWDER-ENDOHS

Study type

Interventional

Funder types

Other

Identifiers

NCT06096948

B4062023000141 (Other Identifier)

NEXPOWDER-ENDOHS

P2023/250 (Other Identifier)

Details and patient eligibility

About

Safety and effectiveness of a new hemostatic system to prevent delayed bleeding after endoscopic resection in a selected high-risk population (NEXPOWDER- ENDOHS).

Indication:

Patients with indication of endoscopy resection by endoscopic mucal resection (EMR) or endoscopic submucosal dissection (ESD) with high risk of delayed bleeding (≥5%).

Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Full description

Hypotheses:

The use of NexpowderTM after upper and lower gastrointestinal ESD or EMR of ≥20mm in high-risk population will prevent and decrease delayed bleeding to less than 5%.

Study design:

This is an investigator-initiated, multicentric, international, open-label, non-controlled, prospective study:

All subjects with indications undergo screening and baseline visit,
Informed consent is obtained when scheduling the ESD or EMR procedure,
ESD or EMR is performed, at the end of resection, NexpowderTM is applied on the resected field,
A follow up visit is scheduled at 4 weeks.

Endpoints:

Primary:
Assess the delayed bleeding rate after ESD or EMR of ≥20mm in a selected high-risk population when using NexpowderTM at the end of the procedure.

This hypothesis is that the use of NexpowderTM will reduce the rate of DB from 16% (reported rate in the literature) to less than 5% (excepted observed rate during the study).

Secondary:
Safety of NexpowderTM endoscopic hemostasis system,
Procedure duration and NexpowderTM spaying duration,
Length of stay in hospital,
Post intervention pain,
Adverse events related to the use of NexpowderTM:
Per procedural
Early (up to controlled endoscopy or at 24hours post procedure)
Late (up to 4 weeks follow-up).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: ≥18 year of age at the time of informed consent,
Patients must have given written informed consent,
Subjects with documented lesions with indication of upper or lower endoscopic removal by ESD or EMR with high risk of delayed bleeding (+/-16%), namely:
All patients under anticoagulation (vitamin K antagonist, direct anticoagulant, non-fractionated heparin or low molecular weight heparin) or anti-aggregating (P2Y12 receptor antagonists),
Patients without anticoagulation or anti-aggregating with indication of duodenal EMR or ESD (if duodenal cold snare EMR: only under anticoagulant or P2Y12 receptor antagonist),
Resection field of ESD or EMR is ≥ 20mm (same size restriction in case of endoscopic papillectomy).

Exclusion criteria

Resection bed <20mm,
Subject currently enrolled in another interventional confounding research (no contra-indication for image or blood collection in another protocol),
Incapacitated subjects, pregnant or lactating women.