Colon PolypNCT04837690
UEMR for Medium-sized Pedunculated Colon Polyps
An observational study of Colon Polyp, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Polyp
- What is being tested?
- UEMR
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Oct 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients or inpatients requiring polypectomy
Who may be able to join
- Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study.
Who cannot join
- pregnancy,
- inflammatory bowel disease,
- familial polyposis
- the use of anticoagulant therapy or antiplatelet therapy
- the absence of informed patient consent.
- Polyps showing signs of deep submucosal invasion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Underwater Endoscopic Mucosal Resection for Medium-sized Pedunculated Colon Polyps: A Prospective Observational Study
Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.
- Conditions
- Colon Polyp
- Being tested
- UEMR
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UEMRProcedure or surgery
(1) the colorectal lumen was completed deflated with 500-1000 mL sterile water using a flushing pump; (2) the lesion and 2-3 mm of normal mucosa surrounding the base of the polyp were snared and subsequently resected with an electrosurgical generator
| Study group | Role | What they receive |
|---|---|---|
| UEMR | Not described Receives: Procedure: UEMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of bleeding
the bleeding was defined as the active hemorrhage lasted for ≥ 30 s or other condition requires immediate intervention.
Measured: 1 Day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837690
- Sponsor's protocol ID
- AUEMR-1.0
- Status last verified
- Apr 2021
- First submitted
- 7 Apr 2021
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Underwater Endoscopic Mucosal Resection for Medium-sized Pedunculated Colon Polyps: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04837690
- Acronym / sponsor ID
- AUEMR-1.0
- Conditions
- Colon Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UEMR | – | Procedure: UEMR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients or inpatients requiring polypectomy
Key inclusion criteria (1 listed)
- Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study.
Key exclusion criteria (6 listed)
- pregnancy,
- inflammatory bowel disease,
- familial polyposis
- the use of anticoagulant therapy or antiplatelet therapy
- the absence of informed patient consent.
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 |
|---|---|---|
| UEMR(1) the colorectal lumen was completed deflated with 500-1000 mL sterile water using a flushing pump; (2) the lesion and 2-3 mm of normal mucosa surrounding the base of the polyp were snared and subsequently resected with an electrosurgical generator | Procedure or surgery | UEMR |
Primary outcome
The rate of bleeding
Time frame: 1 Day of colonoscopy
the bleeding was defined as the active hemorrhage lasted for ≥ 30 s or other condition requires immediate intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Related trials for Colon Polyp
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
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?
An observational study of Colon Polyp, run by Ningbo No. 1 Hospital 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 6 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 8 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Xu, M.D (+8613486659126, xulei22@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of bleeding (time frame: 1 Day of colonoscopy). 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 8 Apr 2021.