Endoscopic HemostasisNCT01735786
EndoClot for Preventing Rebleeding After Endoscopic Mucosal Resection (EMR)
An observational study of Endoscopic Hemostasis and Colonic Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Hemostasis, Colonic Polyps
- What is being tested?
- EndoClot
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Mar 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment
Who may be able to join
- consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.
Who cannot join
- severe cardiovascular diseases, liver and kidney dysfunction;
- platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
- cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
- cases unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.
- Conditions
- Endoscopic Hemostasis, Colonic Polyps
- Being tested
- EndoClot
- Keywords
- Endoscopic Hemostasis, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoClotDevice
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Subjects in this group will received Endoclot treatment immediately after EMR. Receives: Device: EndoClot | |
| Control group | Subjects in this group will not received any hemostasis treatment after EMR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate after EMR procedure
Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.
Measured: up to 1 week
Secondary outcomes (2)
Mucosal healing after EMR
Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
Measured: up to 1 month
gastrointestinal tract obstruction
Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic HemostasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Zhiguo Liu, M.D., Principal investigator, Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735786
- Sponsor's protocol ID
- 20121125
- Status last verified
- Nov 2012
- First submitted
- 25 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoClotTM Absorbable Polysaccharide Hemostat for Preventing Rbleeding After Endoscopic Mucosal Resection (EMR)
- ClinicalTrials.gov ID
- NCT01735786
- Acronym / sponsor ID
- 20121125
- Conditions
- Endoscopic Hemostasis, Colonic Polyps
- Keywords
- Endoscopic Hemostasis, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 28 Nov 2012 (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.
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Postoperative rebleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This study has been designed to observe the effect of rebleeding prevention after EMR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Device: EndoClotSubjects in this group will received Endoclot treatment immediately after EMR. |
| Control group | – | –Subjects in this group will not received any hemostasis treatment after EMR. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cases of colorectal mucosal and submucosal lesions with intented EMR treatment
Key inclusion criteria (1 listed)
- consecutive cases of colorectal polyps and submucosal lesions with anticipated complete removal endoscopically by EMR.
Key exclusion criteria (4 listed)
- severe cardiovascular diseases, liver and kidney dysfunction;
- platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
- cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
- cases unavailable for 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 |
|---|---|---|
| EndoClotEndoClot hemostat is applied immediately after EMR to achieve hemostasis. | Device | Treatment group |
Primary outcome
Rebleeding rate after EMR procedure
Time frame: up to 1 week
Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.
2 secondary outcomes
Mucosal healing after EMR
Time frame: up to 1 month
gastrointestinal tract obstruction
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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.
Zhiguo Liu, M.D. principal investigator
Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China 710032
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Hemostasis and Colonic Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Nov 2012. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding rate after EMR procedure (time frame: up to 1 week). 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 28 Nov 2012.