Colorectal PolypCOLDSNAP-1NCT04464837
Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm
A study testing Cold Snare Polypectomy of intermediate sized polyps (10-15 mm) in people with Colorectal Polyp and Colorectal Adenoma, run by Technical University of Munich at 1 site in Germany.
Trial summary
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 1 Jun 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for colonoscopy
- signed informed consent
- at least one polyp of the size 10-15mm
- American Society of Anesthesiologists-classification (ASA) I-III
Who cannot join
- American Society of Anesthesiologists-classification (ASA) IV-VI
- Inflammatory bowel disease (IBD)
- known/suspected invasive colorectal cancer
- contraindications for polypectomy
- emergency indication for colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.
In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.
- Conditions
- Colorectal Polyp, Colorectal Adenoma
- Being tested
- Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)
- Keywords
- coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)Device
Also called Olympus SnareMaster® Plus
If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Resection Rate (R0-resection)
Complete resection rate of polyps resected by cold snare polypectomy
Measured: 6 month
Secondary outcomes (3)
Required additional attempts for complete resection during surgery
Where there more than one attempts for complete resection of the polyp during surgery?
Measured: during surgery
Incidence of immediate and delayed bleeding.
Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Measured: 3 weeks
Technical Impossibility of CSP during surgery
Necessity of changing to HSP, if CSP is technically not possible
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2021 (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 Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Proof-Of-Concept
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monther Bajbouj, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464837
- Sponsor's protocol ID
- COLDSNAP-1
- Acronym
- COLDSNAP-1
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulrich JD, Rechberger P, Bachmann J, Herner A, V Figura G, Lahmer T, Phillip V, Mayr U, Haller B, Jesinghaus M, Schmid RM, Abdelhafez M, Schlag C. Efficacy and Safety of Cold Snare Polypectomy of Colorectal Polyps 10-15 mm with a Hybrid Snare: A Prospective Observational Pilot Study. Digestion. 2023;104(5):391-399. doi: 10.1159/000530642. Epub 2023 Jun 16.
PubMed 37331350
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial
- ClinicalTrials.gov ID
- NCT04464837
- Acronym / sponsor ID
- COLDSNAP-1 / COLDSNAP-1
- Conditions
- Colorectal Polyp, Colorectal Adenoma
- Keywords
- coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 20 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.
In this feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Proof-Of-Concept
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for colonoscopy
- signed informed consent
- at least one polyp of the size 10-15mm
- American Society of Anesthesiologists-classification (ASA) I-III
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists-classification (ASA) IV-VI
- Inflammatory bowel disease (IBD)
- known/suspected invasive colorectal cancer
- contraindications for polypectomy
- emergency indication for colonoscopy
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 |
|---|---|---|
| Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)Also: Olympus SnareMaster® PlusIf an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare | Device | – |
Primary outcome
Complete Resection Rate (R0-resection)
Time frame: 6 month
Complete resection rate of polyps resected by cold snare polypectomy
3 secondary outcomes
Required additional attempts for complete resection during surgery
Time frame: during surgery
Incidence of immediate and delayed bleeding.
Time frame: 3 weeks
Technical Impossibility of CSP during surgery
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 37331350Ulrich JD, Rechberger P, Bachmann J, Herner A, V Figura G, Lahmer T, Phillip V, Mayr U, Haller B, Jesinghaus M, Schmid RM, Abdelhafez M, Schlag C. Efficacy and Safety of Cold Snare Polypectomy of Colorectal Polyps 10-15 mm with a Hybrid Snare: A Prospective Observational Pilot Study. Digestion. 2023;104(5):391-399. doi: 10.1159/000530642. Epub 2023 Jun 16.
- 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 Cold Snare Polypectomy of intermediate sized polyps (10-15 mm) in people with Colorectal Polyp and Colorectal Adenoma, run by Technical University of Munich at 1 site in Germany.
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 4 inclusion and 5 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 9 Jul 2020. 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 Germany. 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?
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?
Complete Resection Rate (R0-resection) (time frame: 6 month). 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 NCT04464837, 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 9 Jul 2020.