Colonic PolypNCT05930041
Injured Submucosal Arteries After CSP for 10-19 mm Nonpedunculated Colorectal Polyps.
A study testing Experimental CSP and Active Comparator HS-EMR in people with Colonic Polyp, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Experimental CSP and Active Comparator HS-EMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- at least one polyp sized 10-19 mm (Paris classification Is or IIa) revealed by endoscopic examination.
Who cannot join
- American Society of Anesthesiologists status class 3 or above
- poor bowel preparation (Boston Bowel Preparation Scale <6 points)
- endoscopic features indicating submucous infiltration or malignancy
- oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
- a history of colorectal resection
- emergent colonoscopy (haemodynamic instability and/or continued active gastrointestinal bleeding and/or requiring intensive care patients)
Show all 9Show fewer
- inflammatory bowel disease, familial polyposis and colorectal cancer
- pregnancy or lactation
- severe cardiopulmonary dysfunction, cirrhosis, chronic kidney disease, other malignant tumours or severe infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Presence of Injured Submucosal Arteries After Cold Snare Polypectomy(CSP) is Lower Than That of Conventional Hot Snare Endoscopic Mucosal Resection (HS-EMR) for 10-19 mm Nonpedunculated Colorectal Polyps.
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CSP of 10-19 mm nonpedunculated colorectal polyps.
Read the detailed description
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CS-EMR of 10-19 mm nonpedunculated colorectal polyps. The primary outcome measure was the presence of injured submucosal arteries detected in the submucosal layer. The secondary outcomes included immediate bleeding and the frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy. Immediate bleeding was defined as spurting or oozing which continued for more than 30 seconds.
- Conditions
- Colonic Polyp
- Being tested
- Experimental CSP, Active Comparator HS-EMR
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental CSPProcedure or surgery
Either CSP is performed for 10-19 mm nonpedunculated colorectal polyps.
Active Comparator HS-EMRProcedure or surgery
Either HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps.
| Study group | Role | What they receive |
|---|---|---|
| CSP | Experimental | Not described Receives: Procedure: Experimental CSP |
| HS-EMR | Active comparator | Not described Receives: Procedure: Active Comparator HS-EMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of injured submucosal arteries detected in the submucosal layer.
the presence of injured submucosal arteries detected in the submucosal layer.
Measured: 1 day
Secondary outcomes (3)
Delayed bleeding
The frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy.
Measured: 14 days
Immediate bleedling
The frequency of Immediate bleeding which was defined as spurting or oozing which continued for more than 30 seconds.
Measured: 1 day
One-year adenoma recurrence rate
Adenoma recurrence rate at the resection site at one-year follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930041
- Sponsor's protocol ID
- CSP/HSEMR
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurasawa S, Horiuchi I, Kajiyama M, Kitahara H, Terashima T, Horiuchi A. Injured submucosal arteries following cold snare polypectomy are significantly fewer versus those after endoscopic mucosal resection for 10-19-mm nonpedunculated colorectal polyps. DEN Open. 2025 Mar 18;5(1):e70099. doi: 10.1002/deo2.70099. eCollection 2025 Apr.
PubMed 40104570
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Injured Submucosal Arteries After Cold Snare Polypectomy(CSP) is Lower Than That of Conventional Hot Snare Endoscopic Mucosal Resection (HS-EMR) for 10-19 mm Nonpedunculated Colorectal Polyps.
- ClinicalTrials.gov ID
- NCT05930041
- Acronym / sponsor ID
- CSP/HSEMR
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jul 2023 (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.
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CSP of 10-19 mm nonpedunculated colorectal polyps.
Detailed description
Cold polypectomy has the advantages of simple operation, less time-consuming and fewer complications. Guidelines have recommended cold snare polypectomy (CSP) to resect small polyps sized <9 mm. CSP was designed to improve the complete resection rate and reduce adverse events. Investigators hypothesize that CSP is better than conventional hot snare endoscopic mucosal resection (HS-EMR) in the presence of injured submucosal arteries detected in the submucosal layer for 10-19 mm nonpedunculated colorectal polyps, resulting in lower delayed bleeding after CS-EMR of 10-19 mm nonpedunculated colorectal polyps. The primary outcome measure was the presence of injured submucosal arteries detected in the submucosal layer. The secondary outcomes included immediate bleeding and the frequency of delayed bleeding requiring endoscopic treatment within 2 weeks after polypectomy. Immediate bleeding was defined as spurting or oozing which continued for more than 30 seconds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSP | Experimental | Procedure: Experimental CSP |
| HS-EMR | Active comparator | Procedure: Active Comparator HS-EMR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least one polyp sized 10-19 mm (Paris classification Is or IIa) revealed by endoscopic examination.
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists status class 3 or above
- poor bowel preparation (Boston Bowel Preparation Scale <6 points)
- endoscopic features indicating submucous infiltration or malignancy
- oral anticoagulants,or antiplatelet agents, or known blood coagulation disorders, or bleeding tendency
- a history of colorectal 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 |
|---|---|---|
| Experimental CSPEither CSP is performed for 10-19 mm nonpedunculated colorectal polyps. | Procedure or surgery | CSP |
| Active Comparator HS-EMREither HS-EMR is performed for 10-19 mm nonpedunculated colorectal polyps. | Procedure or surgery | HS-EMR |
Primary outcome
the presence of injured submucosal arteries detected in the submucosal layer.
Time frame: 1 day
the presence of injured submucosal arteries detected in the submucosal layer.
3 secondary outcomes
Delayed bleeding
Time frame: 14 days
Immediate bleedling
Time frame: 1 day
One-year adenoma recurrence rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 40104570Kurasawa S, Horiuchi I, Kajiyama M, Kitahara H, Terashima T, Horiuchi A. Injured submucosal arteries following cold snare polypectomy are significantly fewer versus those after endoscopic mucosal resection for 10-19-mm nonpedunculated colorectal polyps. DEN Open. 2025 Mar 18;5(1):e70099. doi: 10.1002/deo2.70099. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental CSP and Active Comparator HS-EMR in people with Colonic Polyp, run by Showa Inan General Hospital at 1 site in Japan.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 Japan. 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?
This study is still under way. Results are not available in the source record yet.
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?
the presence of injured submucosal arteries detected in the submucosal layer. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930041, which also lists 1 linked publication.
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 10 Aug 2026.