Diminutive Colorectal PolypNCT02036047
The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
A study testing exclusive cold polypectomy snare (Exacto cold snare, product number 00711115) and Regular polypectomy snare (Snare Master, SD-210U-10) in people with Diminutive Colorectal Polyp and Cold Snare Polypectomy, run by Showa Inan General Hospital at 1 site in Japan.
Trial summary
The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diminutive Colorectal Polyp, Cold Snare Polypectomy, Polypectomy Snare
- What is being tested?
- exclusive cold polypectomy snare (Exacto cold snare, product number 00711115) and Regular polypectomy snare (Snare Master, SD-210U-10)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Oct 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with colorectal polyps up to 10 mm in diameter.
Who cannot join
- patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical resection.
Trial locations and contacts
1 site in 1 country.
About this study
The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.
- Conditions
- Diminutive Colorectal Polyp, Cold Snare Polypectomy, Polypectomy Snare, Complete Resection Rate, Postpolypectomy Bleeding
- Being tested
- exclusive cold polypectomy snare (Exacto cold snare, product number 00711115), Regular polypectomy snare (Snare Master, SD-210U-10)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)Device
Regular polypectomy snare (Snare Master, SD-210U-10)Device
| Study group | Role | What they receive |
|---|---|---|
| Exclusive cold polypectomy snare | Experimental | All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using an exclusive cold polypectomy snare (Exacto cold snare). The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy. Receives: Device: exclusive cold polypectomy snare (Exacto cold snare, product number 00711115) |
| regular polypectomy snare | Active comparator | All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using a regular polypectomy snare. The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy. Receives: Device: Regular polypectomy snare (Snare Master, SD-210U-10) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection rate of colorectal polyps
The complete resection rate of colorectal polyps based on the pathological examination.
Measured: 2 weeks
Secondary outcomes (1)
Postpolypectomy bleeding
Postpolypectomy bleeding within two weeks after cold snare polypectomy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
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 Diminutive Colorectal 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT02036047
- Sponsor's protocol ID
- Exacto
- Status last verified
- Nov 2014
- First submitted
- 11 Jan 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Horiuchi A, Hosoi K, Kajiyama M, Tanaka N, Sano K, Graham DY. Prospective, randomized comparison of 2 methods of cold snare polypectomy for small colorectal polyps. Gastrointest Endosc. 2015 Oct;82(4):686-92. doi: 10.1016/j.gie.2015.02.012. Epub 2015 Apr 25.
PubMed 25922251
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
- ClinicalTrials.gov ID
- NCT02036047
- Acronym / sponsor ID
- Exacto
- Conditions
- Diminutive Colorectal Polyp, Cold Snare Polypectomy, Polypectomy Snare, Complete Resection Rate, Postpolypectomy Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Jan 2014 (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.
The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal polyps, resulting in an increase in the complete resection rate and a decrease in the adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive cold polypectomy snare | Experimental | Device: exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using an exclusive cold polypectomy snare (Exacto cold snare). The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy. |
| regular polypectomy snare | Active comparator | Device: Regular polypectomy snare (Snare Master, SD-210U-10)All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed using a regular polypectomy snare. The technique is cold snare resection of the polyp without tenting without electrocautery and then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is not performed after cold snare polypectomy. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with colorectal polyps up to 10 mm in diameter.
Key exclusion criteria (1 listed)
- patients are less than 20 years old, pregnant, ASA class III and IV, allergic to propofol used or its components (soybeans or eggs), with poor bowel preparation, and with previous colorectal surgical 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 |
|---|---|---|
| exclusive cold polypectomy snare (Exacto cold snare, product number 00711115) | Device | Exclusive cold polypectomy snare |
| Regular polypectomy snare (Snare Master, SD-210U-10) | Device | regular polypectomy snare |
Primary outcome
Complete resection rate of colorectal polyps
Time frame: 2 weeks
The complete resection rate of colorectal polyps based on the pathological examination.
1 secondary outcome
Postpolypectomy bleeding
Time frame: 2 weeks
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 4 Nov 2014.
- Derived from this study: PubMed 25922251Horiuchi A, Hosoi K, Kajiyama M, Tanaka N, Sano K, Graham DY. Prospective, randomized comparison of 2 methods of cold snare polypectomy for small colorectal polyps. Gastrointest Endosc. 2015 Oct;82(4):686-92. doi: 10.1016/j.gie.2015.02.012. Epub 2015 Apr 25.
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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 exclusive cold polypectomy snare (Exacto cold snare, product number 00711115) and Regular polypectomy snare (Snare Master, SD-210U-10) in people with Diminutive Colorectal Polyp and Cold Snare Polypectomy, 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 1 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 4 Nov 2014. 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?
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?
Complete resection rate of colorectal polyps (time frame: 2 weeks). 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 NCT02036047, 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 4 Nov 2014.