Colon PolypNCT06601426
NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study
A study testing CSP in people with Colon Polyp, run by Qianfoshan Hospital at 1 site in China.
Trial summary
NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. Read more about this study
- Who is it for?
- Ages 15 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp
- What is being tested?
- CSP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Jun 2022
- 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 15 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ① Outpatient or inpatient patients aged 18-85 years old;
- ② Untamed, subpodial, and flat polyps with a diameter of 5-9mm (Paris classification: O-Is O-Isp、O-IIa；JNET Classification: Typel, Type2A);
- ③ Patients who agree to participate in this study.
Who cannot join
- Individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (PT prolongation greater than 3 seconds);
- Polyp diameter<5mm or ≥ 10mm, morphology does not conform or JNET classification ≥ Type 2B;
- Individuals with severe heart, lung, liver and kidney dysfunction or severe mental disorders who cannot cooperate with the examination; ④ Patients with intestinal obstruction, inflammatory bowel disease, Lynch syndrome, and familial adenomatous polyposis diagnosis;
- Pregnancy; ⑥ Those who fail to meet the requirements for bowel cleansing preparation (BBPS<6 points).
Trial locations and contacts
1 site in 1 country.
About this study
NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. And then formulate a standard operating procedure for cold snare removal of polyps.
- Conditions
- Colon Polyp
- Being tested
- CSP
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSPProcedure or surgery
cold snare polypectomy
| Study group | Role | What they receive |
|---|---|---|
| NBI-NearFocus | Other | Narrow Band Imaging-NearFocus Receives: Procedure: CSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological complete resection rate
Measured: 2-3 days
Secondary outcomes (1)
Complete recovery rate of polyps
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyong Jia, Qianfoshan Hospital
- Investigators
- Xinyong Jia, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601426
- Sponsor's protocol ID
- 147258368
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study
- ClinicalTrials.gov ID
- NCT06601426
- Acronym / sponsor ID
- 147258368
- Conditions
- Colon Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Sep 2024 (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.
NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. And then formulate a standard operating procedure for cold snare removal of polyps.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBI-NearFocus | Other | Procedure: CSPNarrow Band Imaging-NearFocus |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ① Outpatient or inpatient patients aged 18-85 years old;
- ② Untamed, subpodial, and flat polyps with a diameter of 5-9mm (Paris classification: O-Is O-Isp、O-IIa；JNET Classification: Typel, Type2A);
- ③ Patients who agree to participate in this study.
Key exclusion criteria (4 listed)
- Individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (PT prolongation greater than 3 seconds);
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 |
|---|---|---|
| CSPcold snare polypectomy | Procedure or surgery | NBI-NearFocus |
Primary outcome
Histopathological complete resection rate
Time frame: 2-3 days
1 secondary outcome
Complete recovery rate of polyps
Time frame: 2-3 days
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Xinyong Jia principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSP in people with Colon Polyp, run by Qianfoshan 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 3 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 19 Sep 2024. 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?
Histopathological complete resection rate (time frame: 2-3 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 19 Sep 2024.