NCT06096948

Brief Summary

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%.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 10, 2023

Last Update Submit

October 20, 2023

Conditions

Gastro Intestinal BleedingPolyps

Outcome Measures

Primary Outcomes (2)

  • Safety in terms of Adverse Events (AE related to Nexpowder)

    * number of intraprocedural complications (perforation,…) * number of post-procedure complications (delayed perforation, peritonitis,..)

    1 month

  • Efficacy of Nexpowder in changing the delayed bleeding rate

    Decrease the delayed bleeding rate

    1 month

Study Arms (1)

NEXPOWDER-ENDOHS

EXPERIMENTAL

Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.

Device: NEXPOWDER-ENDOHS

Interventions

NEXPOWDER-ENDOHSDEVICE

Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.

NEXPOWDER-ENDOHS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Gasthuisberg (KUL)

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

AZ Sint-Jan Brugge-Oostende

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

AZ Delta Campus Rumbeke

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)

Brussels, 1070, Belgium

RECRUITING

Cliniques universitaires Saint-Luc (UCL)

Brussels, 1200, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

Groupe Santé CHC - Clinique du MontLégia

Liège, 4000, Belgium

RECRUITING

Amsterdam UMC - Location VUMC

Amsterdam, 1081, Netherlands

NOT YET RECRUITING

Amsterdam UMC - Location AMC

Amsterdam, 1105, Netherlands

NOT YET RECRUITING

UMC Utrecht

Utrecht, 3584, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Gastrointestinal HemorrhagePolyps

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Central Study Contacts

Arnaud Lemmers

CONTACT

+3225556559arnaud.lemmers@hubruxelles.be

Julia Chaves Rodriguez

CONTACT

+3225551779julia.chaves.rodriguez@ulb.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Endoscopy Unit, Director of Clinic Department of Gastroenterology, Hepatopancreatology and Digestive Oncology Erasme Hospital,

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 24, 2023

Study Start

October 15, 2023

Primary Completion

April 30, 2024

Study Completion

July 30, 2024

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(3)BE(9)