Colorectal CancerNEXBLEEDNCT05247515
Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Colorectal Endoscopic Mucosal Resection
A study testing Endoscopic mucosal resection with nexpowder in people with Colorectal Cancer, run by Gabriel RAHMI at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Endoscopic mucosal resection with nexpowder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2022to 1 Aug 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years old
- Indication of EMR for a superficial nonpedunculated colorectal lesion
- Higher risk of bleeding (score GSEED RE2 ≥ 7*)
- Score GSEED RE2 (Albeniz et al GIE 2020):
- Proximal location (cecum to transverse included) : 3 points
- Antiplatelets or anticoagulation use: 3 points
- Lesion size ≥ 40 mm: 1 point
- ASA III-IV or major comorbidity: 1 point
Who cannot join
- Patients susceptible to allergic reactions to certain substances in Nexpowder
- More than one colorectal lesion
- Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
- Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
- Recurrent or residual lesion after endoscopic or surgical resection
- Poor bowel preparation quality (Boston score < 6)
Show all 18Show fewer
- Inflammatory bowel disease (IBD)
- Patients with a platelet count of 50,000/mm3 or less
- Patients with acquired (non-medicated) or inherited bleeding disorders
- Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement)
- Contraindication to general anesthesia
- Women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding.
- Children, immunocompromised persons and persons over 90 years of age
- Patients already participating or scheduled to participate in other clinical trials
- Lesion previously resected by endoscopy
- Patient with an initial metastatic lesion before colonoscopy
- Patient unable to give personal consent
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection
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
- Colorectal Cancer
- Being tested
- Endoscopic mucosal resection with nexpowder
- Keywords
- Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosal resection with nexpowderDevice
At 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.
| Study group | Role | What they receive |
|---|---|---|
| Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels | Experimental | To compare of the risk of bleeding after EMR application of nexpower (not a drug but a device with CE mark) on the resect area (scar) to cover the whole surface of mucosal resection. Receives: Device: Endoscopic mucosal resection with nexpowder |
| standard procedure : EMR with coagulation of visible vessels | No intervention | After EMR with coagulation of visible vessels, if the patient is randomized in the comparative group, not nexpowder will be applied on the scar (common practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe post-resection bleeding rate up to Day 30
Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss > 2 g/dl
Measured: 30 days
Secondary outcomes (7)
The success rate of Nexpowder application
Number of patients with a satisfactory covering of the scar by the powder
Measured: Day of resection
Delayed perforation rate
Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner
Measured: 30 days
Stenosis rate
Number of patients with the impossibility to pass through the lumen with a standard colonoscope
Measured: 30 days
Post coagulation syndrome
Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner.
Measured: 30 days
Bowel obstruction rate
Number of patients with at least one symptomatic bowel obstruction.
Measured: 30 days
Rate of cases requiring transfusion related to post-EMR bleeding
Number of patients for whom at least one transfusion was ordered after the EMR
Measured: 30 days
Rate and duration of hospitalizations
Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriel RAHMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriel RAHMI, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247515
- Sponsor's protocol ID
- SFED 154
- Acronym
- NEXBLEED
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection
- ClinicalTrials.gov ID
- NCT05247515
- Acronym / sponsor ID
- NEXBLEED / SFED 154
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal polypectomy, endoscopic mucosal resection, hemostatic powder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Gabriel RAHMIUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels | Experimental | Device: Endoscopic mucosal resection with nexpowderTo compare of the risk of bleeding after EMR application of nexpower (not a drug but a device with CE mark) on the resect area (scar) to cover the whole surface of mucosal resection. |
| standard procedure : EMR with coagulation of visible vessels | No intervention | –After EMR with coagulation of visible vessels, if the patient is randomized in the comparative group, not nexpowder will be applied on the scar (common practice) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- More than 18 years old
- Indication of EMR for a superficial nonpedunculated colorectal lesion
- Higher risk of bleeding (score GSEED RE2 ≥ 7*)
- Proximal location (cecum to transverse included) : 3 points
- Antiplatelets or anticoagulation use: 3 points
Key exclusion criteria (18 listed)
- Patients susceptible to allergic reactions to certain substances in Nexpowder
- More than one colorectal lesion
- Suspicion of invasive cancer (Kudo V, Sano IIIb, Connect III), macronodular more than 1 cm, depressed area (Paris IIc)
- Pedunculated polyps (Ip from Paris classification) or ulcerated polyps (III)
- Recurrent or residual lesion after endoscopic or surgical resection
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 |
|---|---|---|
| Endoscopic 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. | Device | Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels |
Primary outcome
Severe post-resection bleeding rate up to Day 30
Time frame: 30 days
Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss > 2 g/dl
7 secondary outcomes
The success rate of Nexpowder application
Time frame: Day of resection
Delayed perforation rate
Time frame: 30 days
Stenosis rate
Time frame: 30 days
Post coagulation syndrome
Time frame: 30 days
Bowel obstruction rate
Time frame: 30 days
Rate of cases requiring transfusion related to post-EMR bleeding
Time frame: 30 days
Rate and duration of hospitalizations
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic mucosal resection with nexpowder in people with Colorectal Cancer, run by Gabriel RAHMI at 1 site in France.
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 8 inclusion and 18 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Gabriel RAHMI, MD (+33(0)156092000, gabriel.rahmi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe post-resection bleeding rate up to Day 30 (time frame: 30 days). 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 21 Feb 2022.