Colonic PolypPhase 4NCT02688699
Additive Hemostatic Efficacy of EndoClot After EMR or ESD in the Gastrointestinal Tract
A Phase 4 study testing EndoClot in people with Colonic Polyp and Colonic Neoplasms, run by University of Turin, Italy.
Trial summary
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp, Colonic Neoplasms, Colonic Dysplasia
- What is being tested?
- EndoClot
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Mar 2024
- Phase
- Phase 4
- 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
- >18 years old
- lesions suitable for EMR or ESD
- > 20 mm
- site in the right colon
Who cannot join
- Severe cardiovascular pathologies
- Liver and Urinary dysfunctions
- Hematologic diseases
- Pregnancy and breast feeding
- impossible follow-up
- platelet and coagulation disorders (PLT < 50 x 109/L, INR > 2)
- Sensitivity or allergy to the drug
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Dysplasia
- Being tested
- EndoClot
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoClotProcedure or surgery
All patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used.
Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs.
| Study group | Role | What they receive |
|---|---|---|
| EndoClot | Experimental | spraying of Endoclot powder after EMR or ESD Receives: Procedure: EndoClot |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of EndoClotTM in preventing post-procedural bleeding
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startSep 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Arezzo, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688699
- Sponsor's protocol ID
- 12243648
- Status last verified
- May 2023
- First submitted
- 17 Feb 2016
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicenter Prospective Randomized Trial to Compare Additive Hemostatic Efficacy of EndoClot System to Prevent Bleeding After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Lesions in the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT02688699
- Acronym / sponsor ID
- 12243648
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Dysplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- 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.
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoClot | Experimental | Procedure: EndoClotspraying of Endoclot powder after EMR or ESD |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- lesions suitable for EMR or ESD
- > 20 mm
- site in the right colon
Key exclusion criteria (7 listed)
- Severe cardiovascular pathologies
- Liver and Urinary dysfunctions
- Hematologic diseases
- Pregnancy and breast feeding
- impossible follow-up
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 |
|---|---|---|
| EndoClotAll patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used. Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs. | Procedure or surgery | EndoClot |
Primary outcome
effectiveness of EndoClotTM in preventing post-procedural bleeding
Time frame: 14 days
The investigators want to verify in a randomised trial, the effectiveness of EndoClotTM in preventing post-procedural bleeding after EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection) for sessile lesions >20 mm in the right colon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EndoClot in people with Colonic Polyp and Colonic Neoplasms, run by University of Turin, Italy.
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 4 inclusion and 7 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Alberto Arezzo, MD (+393358378243, alberto.arezzo@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of EndoClotTM in preventing post-procedural bleeding (time frame: 14 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 16 May 2023.