Gastro Intestinal BleedingNEX-ENDOHSNCT06096948
Nexpowder to Prevent Delayed Bleeding After Endoscopic Resection
A study testing NEXPOWDER-ENDOHS in people with Gastro Intestinal Bleeding and Polyps, run by Erasme University Hospital at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Bleeding, Polyps
- What is being tested?
- NEXPOWDER-ENDOHS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Oct 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Belgium9 sites, 9 recruiting
- Recruiting
AZ Sint-Jan Brugge-Oostende
Bruges, West-Vlaanderen, 8000
Christophe Snauwaert, +3250452180, christophe.snauwaert@azsintjan.be
Nathalie Backers, +3250452180, nathalie.backers@azsintjan.be
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Pierre Eisendrath, MD, PhD, +3225354856, pierre.eisendrath@stpierre-bru.be
Katty Renard, +3225354856, katty.renard@stpierre-bru.be
- Recruiting
HUB - Hôpital Erasme, Service de Gastro-Entérologie (ULB)
Brussels, 1070
Arnaud Lemmers, MD,PhD, +3225556559, arnaud.lemmers@erasme.ulb.ac.be
Julia Chaves Rodriguez, MD, +3225551779, Julia.Chaves.Rodriguez@ulb.be
- Recruiting
Cliniques universitaires Saint-Luc (UCL)
Brussels, 1200
Pierre Deprez, MD, PhD, +3227642849, pdeprez@saintluc.uclouvain.be
- Recruiting
AZ Maria Middelares
Ghent, Oost-Vlaanderen, 9000
Pieter Dewint, MD, PhD, +3292467141, pieter.dewint@azmmsj.be
Margaux Vansteelant, +3292467145, Margaux.Vansteelant@azmmsj.be
- Recruiting
UZ Gent
Ghent, 9000
David Tate, MD, PhD, +3293322300, David.tate@uzgent.be
Karolien Haenebalcke, +3293322300, Karolien.Haenebalcke@uzgent.be
- Recruiting
UZ Gasthuisberg (KUL)
Leuven, Vlaams Brabant, 3000
Raf Bisschops, MD, PhD, +3216341946, raf.bisschops@uzleuven.be
Chelsea Camps, +3216341946, chelsea.camps@uzleuven.be
- Recruiting
Groupe Santé CHC - Clinique du MontLégia
Liège, 4000
Philippe Leclercq, +3243554211, philippe.leclercq@chc.be
Alexandro Maniglia, +3243554211, alexandro.maniglia@chc.be
- Recruiting
AZ Delta Campus Rumbeke
Roeselare, West-Vlaanderen, 8800
Dominiek De Wulf, +3251237172, Dominiek.DeWulf@azdelta.be
Katleen Kerstens, +3251237172, katleen.kerstens@azdelta.be
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Amsterdam UMC - Location VUMC
Amsterdam, 1081
Roos Pouw, MD, r.e.pouw@amsterdamumc.nl
Jacques Bergman, MD
- Not yet recruiting
Amsterdam UMC - Location AMC
Amsterdam, 1105
Barbara Bastiaansen, MD, b.a.bastiaansen@amsterdamumc.nl
Evelien Dekker, MD
- Not yet recruiting
UMC Utrecht
Utrecht, 3584
Leon Moons, L.M.G.Moons@umcutrecht.nl
Bas Weusten, b.l.a.weusten@umcutrecht.nl
About this study
Official title: Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population
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%.
Read the detailed 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).
- Conditions
- Gastro Intestinal Bleeding, Polyps
- Being tested
- NEXPOWDER-ENDOHS
- Medical subject headings
- Gastrointestinal Hemorrhage, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEXPOWDER-ENDOHSDevice
Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding.
| Study group | Role | What they receive |
|---|---|---|
| NEXPOWDER-ENDOHS | Experimental | Standard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding. Receives: Device: NEXPOWDER-ENDOHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of Adverse Events (AE related to Nexpowder)
- number of intraprocedural complications (perforation,…)
- number of post-procedure complications (delayed perforation, peritonitis,..)
Measured: 1 month
Efficacy of Nexpowder in changing the delayed bleeding rate
Decrease the delayed bleeding rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lemmers Arnaud, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096948
- Sponsor's protocol ID
- NEXPOWDER-ENDOHS
- Other IDs
- P2023/250, B4062023000141
- Acronym
- NEX-ENDOHS
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a New Hemostatic System to Prevent Delayed Bleeding After Endoscopic Resection in a Selected High-risk Population
- ClinicalTrials.gov ID
- NCT06096948
- Acronym / sponsor ID
- NEX-ENDOHS / NEXPOWDER-ENDOHS
- Conditions
- Gastro Intestinal Bleeding, Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEXPOWDER-ENDOHS | Experimental | Device: NEXPOWDER-ENDOHSStandard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEXPOWDER-ENDOHSStandard of care ESD or EMR procedure and application of Nexpowder on the resection site to prevent delayed bleeding. | Device | NEXPOWDER-ENDOHS |
Primary outcome
Safety in terms of Adverse Events (AE related to Nexpowder)
Time frame: 1 month
* number of intraprocedural complications (perforation,…) * number of post-procedure complications (delayed perforation, peritonitis,..)
Efficacy of Nexpowder in changing the delayed bleeding rate
Time frame: 1 month
Decrease the delayed bleeding rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEXPOWDER-ENDOHS in people with Gastro Intestinal Bleeding and Polyps, run by Erasme University Hospital at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Lemmers (+3225556559, arnaud.lemmers@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in terms of Adverse Events (AE related to Nexpowder) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.