Colorectal PolypsNCT00855790
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
A study testing evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep in people with Colorectal Polyps, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- colon polyps less than 6 mm
Who cannot join
- no colon polyps
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.
- Conditions
- Colorectal Polyps
- Being tested
- evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep
- Keywords
- evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcepOther
Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.
| Study group | Role | What they receive |
|---|---|---|
| RJ3 Biopsy Forcep | Active comparator | use of RJ3 Biopsy forcep for the polypectomy Receives: Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep |
| RJ4 Biopsey Forcep | Active comparator | Use of RJ$ biopsy forcep for polypectomy Receives: Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete endoscopic (visual) eradication of the polyp with the first forceps bite
Measured: one year
Secondary outcomes (3)
Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite
Measured: one year
Complete pathologic eradication of the polyp on the first forceps bite.
Measured: one year
Correlate endoscopic with pathologic eradication
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionNov 2009
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 PolypsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855790
- Sponsor's protocol ID
- colon polypectomy
- Status last verified
- Jul 2015
- First submitted
- 2 Mar 2009
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
PubMed 22196811
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter
- ClinicalTrials.gov ID
- NCT00855790
- Acronym / sponsor ID
- colon polypectomy
- Conditions
- Colorectal Polyps
- Keywords
- evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Mar 2009 (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 purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RJ3 Biopsy Forcep | Active comparator | Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcepuse of RJ3 Biopsy forcep for the polypectomy |
| RJ4 Biopsey Forcep | Active comparator | Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcepUse of RJ$ biopsy forcep for polypectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- colon polyps less than 6 mm
Key exclusion criteria (1 listed)
- no colon polyps
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 |
|---|---|---|
| evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcepUse of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm. | Other | RJ3 Biopsy Forcep, RJ4 Biopsey Forcep |
Primary outcome
Complete endoscopic (visual) eradication of the polyp with the first forceps bite
Time frame: one year
3 secondary outcomes
Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite
Time frame: one year
Complete pathologic eradication of the polyp on the first forceps bite.
Time frame: one year
Correlate endoscopic with pathologic eradication
Time frame: one year
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 23 Jul 2015.
- Derived from this study: PubMed 22196811Draganov PV, Chang MN, Alkhasawneh A, Dixon LR, Lieb J, Moshiree B, Polyak S, Sultan S, Collins D, Suman A, Valentine JF, Wagh MS, Habashi SL, Forsmark CE. Randomized, controlled trial of standard, large-capacity versus jumbo biopsy forceps for polypectomy of small, sessile, colorectal polyps. Gastrointest Endosc. 2012 Jan;75(1):118-26. doi: 10.1016/j.gie.2011.08.019.
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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.
Peter Draganov, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep in people with Colorectal Polyps, run by University of Florida at 1 site in United States.
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 23 Jul 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 United States. 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 endoscopic (visual) eradication of the polyp with the first forceps bite (time frame: one year). 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 NCT00855790, 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 23 Jul 2015.