NeoplasmsPhase 4NCT01471756
Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia
A Phase 4 study of Neoplasms and Gastric Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Gastric Cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2014
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sessile colorectal polyp
- laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater
Who cannot join
- Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
- Inflammatory bowel disease patients
- Coagulopathy ( INR> 1.5) that cannot be corrected
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps
The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.
Read the detailed description
The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.
- Conditions
- Neoplasms, Gastric Cancer
- Being tested
- Standard of Care Procedure as described in ARM
- Keywords
- sessile neoplasms, flat neoplasms, gastric cancer
- Medical subject headings
- Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Procedure as described in ARMProcedure or surgery
Standard of Care Procedure as described in ARM
| Study group | Role | What they receive |
|---|---|---|
| iSnare with Gonak solution | Experimental | Not described Receives: Procedure: Standard of Care Procedure as described in ARM |
| Snaremaster braided snare with Gonak solution | Experimental | Not described Receives: Procedure: Standard of Care Procedure as described in ARM |
| iSnare with saline solution | Experimental | Not described Receives: Procedure: Standard of Care Procedure as described in ARM |
| Snaremaster braided snare with saline solution | Experimental | Not described Receives: Procedure: Standard of Care Procedure as described in ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Two Devices used in EMR
To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .
Measured: 1 year
Secondary outcomes (1)
Compare the Use of Two Injectates
To compare the use of two injectates (saline versus HPMC mixture) with respect to efficacy as measured by the aforementioned SRQ.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- US Endoscopy
- Responsible party
- Principal investigator, Timothy Woodward, Mayo Clinic
- Investigators
- Timothy A Woodward, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471756
- Sponsor's protocol ID
- 10-008104
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2011
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps
- ClinicalTrials.gov ID
- NCT01471756
- Acronym / sponsor ID
- 10-008104
- Conditions
- Neoplasms, Gastric Cancer
- Keywords
- sessile neoplasms, flat neoplasms, gastric cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- US Endoscopy
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Nov 2011 (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 investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.
Detailed description
The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iSnare with Gonak solution | Experimental | Procedure: Standard of Care Procedure as described in ARM |
| Snaremaster braided snare with Gonak solution | Experimental | Procedure: Standard of Care Procedure as described in ARM |
| iSnare with saline solution | Experimental | Procedure: Standard of Care Procedure as described in ARM |
| Snaremaster braided snare with saline solution | Experimental | Procedure: Standard of Care Procedure as described in ARM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sessile colorectal polyp
- laterally spreading lesions as defined by Paris Classification type II and > 1 cm or greater
Key exclusion criteria (3 listed)
- Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
- Inflammatory bowel disease patients
- Coagulopathy ( INR> 1.5) that cannot be corrected
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 |
|---|---|---|
| Standard of Care Procedure as described in ARMStandard of Care Procedure as described in ARM | Procedure or surgery | Snaremaster braided snare with Gonak solution, Snaremaster braided snare with saline solution, iSnare with Gonak solution, iSnare with saline solution |
Primary outcome
Efficacy of Two Devices used in EMR
Time frame: 1 year
To explore the efficacy of two devices used in EMR (iSnare® system versus Snaremaster) as measured by the "Sydney Resection Quotient" (SRQ). SRQ is defined as "lesion size in mm divided by the number of pieces to resect" .
1 secondary outcome
Compare the Use of Two Injectates
Time frame: 1 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 8 Sep 2014.
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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.
Timothy A Woodward, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Neoplasms and Gastric Cancer, run by Mayo Clinic 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 2 inclusion and 3 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 8 Sep 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of Two Devices used in EMR (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2014.