Colon PolypsNCT01665898
Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
A study testing Cold Biopsy forceps and Cold snare biopsy in people with Colon Polyps, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Polyps
- What is being tested?
- Cold Biopsy forceps and Cold snare biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Mar 2015
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients older than 40 years old and
- patients who are receiving colonoscopies and
- patients who have colon polyps
Who cannot join
- patients who have not agreed to the study
- patients with bleeding tendencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.
Read the detailed description
Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.
- Conditions
- Colon Polyps
- Being tested
- Cold Biopsy forceps, Cold snare biopsy
- Keywords
- cold biopsy forceps, cold snare biopsy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Biopsy forcepsProcedure or surgery
removal of polyps using cold biopsy forceps
Cold snare biopsyProcedure or surgery
Removal of colon polyps using cold snare biopsy
| Study group | Role | What they receive |
|---|---|---|
| Cold biopsy forceps | Active comparator | Cold biopsy forceps for removal of colon polyps Receives: Procedure: Cold Biopsy forceps |
| Cold Snare Biopsy | Active comparator | Cold snare biopsy for removal of colon polyps Receives: Procedure: Cold snare biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.
Measured: up to 3 years
Secondary outcomes (1)
Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
We will investigate bleeding rate after removal of colon polyps by these two methods. Bleeding rate will be the number of patients who showed significant bleeding after the procedure divided by the total number of patients who will receive the procedure. Significant bleeding was determined to be ongoing bleeding for more than 30 seconds after the procedure
Measured: participants will be followed up for 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionMar 2015
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 Colon PolypsStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Sung Kim, Incheon St.Mary's Hospital
- Investigators
- Bo-In Lee, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665898
- Sponsor's protocol ID
- IncheonSMH
- Other IDs
- OC12OISI0067
- Status last verified
- Mar 2015
- First submitted
- 9 Aug 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
PubMed 25708763
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Cold Biopsy Forceps Versus Cold Snare Biopsy for Colon Polyps
- ClinicalTrials.gov ID
- NCT01665898
- Acronym / sponsor ID
- IncheonSMH
- Conditions
- Colon Polyps
- Keywords
- cold biopsy forceps, cold snare biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Aug 2012 (estimated)
- 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.
Comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.
Detailed description
Polyps were randomized to be treated with either CSP or CFP. After the initial polypectomy, additional EMR was performed at the polypectomy site to assess the presence of residual polyp tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold biopsy forceps | Active comparator | Procedure: Cold Biopsy forcepsCold biopsy forceps for removal of colon polyps |
| Cold Snare Biopsy | Active comparator | Procedure: Cold snare biopsyCold snare biopsy for removal of colon polyps |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients older than 40 years old and
- patients who are receiving colonoscopies and
- patients who have colon polyps
Key exclusion criteria (2 listed)
- patients who have not agreed to the study
- patients with bleeding tendencies
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 Biopsy forcepsremoval of polyps using cold biopsy forceps | Procedure or surgery | Cold biopsy forceps |
| Cold snare biopsyRemoval of colon polyps using cold snare biopsy | Procedure or surgery | Cold Snare Biopsy |
Primary outcome
Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps
Time frame: up to 3 years
We will investigate the complete removal rate of colon polyps by using two different methods, cold biopsy forceps or cold snare biopsy. After removal of polyps by one of these two methods, the remnant lesion will be biopsied to study if there are any remnant tissues in order to find out the complete removal rate.
1 secondary outcome
Bleeding rate after removal of colon polyps by using cold biopsy forceps or cold snare biopsy
Time frame: participants will be followed up for 1 month
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 26 Mar 2015.
- Derived from this study: PubMed 25708763Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
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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.
Bo-In Lee principal investigator
Incheon St.Mary's 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 Cold Biopsy forceps and Cold snare biopsy in people with Colon Polyps, run by Incheon St.Mary's Hospital at 1 site in South Korea.
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 2 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 26 Mar 2015. 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 South Korea. 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?
Comparing the complete removal rate of cold biopsy forceps versus cold snare biopsy for removing colon polyps (time frame: up to 3 years). 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 NCT01665898, 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 26 Mar 2015.