Investigation of Cold Snare Polypectomy for Removing 10-20 mm 0-Ip Colorectal Polyp

NCT07114380 | Recruiting FDA Device

• 1 other identifier: 202505029RINA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, single-arm feasibility study conducted across multiple hospitals in Taiwan. The goal of this trial is to evaluate whether cold snare polypectomy is a feasible and safe method for removing 10-20 mm pedunculated colorectal polyps. The main questions it aims to answer are:

1. 1.Can cold snare polypectomy achieve complete removal of 10-20 mm pedunculated polyps?
2. 2.What are the rates and types of complications associated with this technique?
3. 3.Undergo colonoscopy as clinically indicated
4. 4.Have 10-20 mm pedunculated polyps removed using cold snare polypectomy if eligible
5. 5.Be monitored for post-procedure outcomes, including pathology results and any complications

Conditions

10-20 mm Pedunculated Colorectal Polyp

Keywords

cold snare polypectomy; pedunculated polyp; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Cold snare polypectomy successful resection rate

  The investigators will record whether each polyp is removed by cold snare polypectomy with or without resistance. These will be considered successful resection cases. Polyps that cannot be removed by cold snare polypectomy and require switching to hot snare polypectomy will be considered failed resection cases.

  From the start of the colonoscopy to completion of the procedure, typically within 1 hour)

Secondary Outcomes (11)

• Number of Polyps with Immediate Bleeding After Cold Snare Polypectomy

  From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

• Number of Participants with Delayed Bleeding After Cold Snare Polypectomy

  From completion of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

• Number of Participants with Perforation

  From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

• Number of Participants with Post-Polypectomy Emergency Department Visits

  From start of colonoscopy until the date of first documented event, assessed up to 14 days post-procedure.

• Polypectomy time

  From the start of the colonoscopy to completion of the procedure, typically within 1 hour.

Study Arms (1)

Cold snare polypectomy

EXPERIMENTAL

Participants in this single-arm study will undergo cold snare polypectomy (CSP) for removal of 10-20 mm pedunculated colorectal polyps identified during clinically indicated colonoscopy. CSP will be performed using standard cold snares without electrocautery. The procedure will be conducted by experienced endoscopists, and all peri-procedural care will follow routine clinical protocols. Outcomes will include complete resection rate, procedure time, and occurrence of adverse events such as immediate or delayed bleeding, perforation, and emergency visits.

Device: Cold snare polypectomy

Interventions

Cold snare polypectomy DEVICE

Unlike traditional hot snare polypectomy or endoscopic mucosal resection, which use electrocautery to resect larger or pedunculated polyps, cold snare polypectomy uses mechanical transection alone without cautery. The procedure is performed using a dedicated cold snare by experienced endoscopists.

Cold snare polypectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years
• Undergoing colonoscopy for any clinical indication
• Found to have a 10-20 mm pedunculated colorectal polyp suitable for cold snare polypectomy

You may not qualify if:

• Age \< 20 years
• Medical contraindications to colonoscopy or polypectomy (e.g., recent myocardial infarction, stroke, severe unstable cardiovascular disease, acute peritonitis, fulminant colitis, perforation, or toxic megacolon)
• Inadequate bowel preparation preventing complete colonoscopy or safe polypectomy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (5)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan

RECRUITING

National Taiwan University Hospital, Jinshan Branch

New Taipei City, 20844, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (6)

• Tseng CH, Chang LC, Wu JL, Chang CY, Chen CY, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Lin JT, Wu MS, Chiu HM. Bleeding Risk of Cold Versus Hot Snare Polypectomy for Pedunculated Colorectal Polyps Measuring 10 mm or Less: Subgroup Analysis of a Large Randomized Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2233-2240. doi: 10.14309/ajg.0000000000002847. Epub 2024 May 9.

  PMID: 38775310 BACKGROUND

• Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.

  PMID: 38670139 BACKGROUND

• Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.

  PMID: 32122632 BACKGROUND

• Copland AP, Kahi CJ, Ko CW, Ginsberg GG. AGA Clinical Practice Update on Appropriate and Tailored Polypectomy: Expert Review. Clin Gastroenterol Hepatol. 2024 Mar;22(3):470-479.e5. doi: 10.1016/j.cgh.2023.10.012. Epub 2023 Nov 28.

  PMID: 38032585 BACKGROUND

• Qu J, Jian H, Li L, Zhang Y, Feng B, Li Z, Zuo X. Effectiveness and safety of cold versus hot snare polypectomy: A meta-analysis. J Gastroenterol Hepatol. 2019 Jan;34(1):49-58. doi: 10.1111/jgh.14464. Epub 2018 Sep 26.

  PMID: 30176072 BACKGROUND

• Chang LC, Chang CY, Chen CY, Tseng CH, Chen PJ, Shun CT, Hsu WF, Chen YN, Chen CC, Huang TY, Tu CH, Chen MJ, Chou CK, Lee CT, Chen PY, Wu MS, Chiu HM. Cold Versus Hot Snare Polypectomy for Small Colorectal Polyps : A Pragmatic Randomized Controlled Trial. Ann Intern Med. 2023 Mar;176(3):311-319. doi: 10.7326/M22-2189. Epub 2023 Feb 21.

  PMID: 36802753 BACKGROUND

Study Officials

• Li-Chun Chang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Yun Wu, MD

CONTACT

+886978232595; kimwu010063@gmail.com

Li-Chun Chang, MD, PhD

CONTACT

+886972651258; lichunchang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 11, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)