Colo-rectal CancerNCT04551014
Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm
A study testing Use of EverLift and Without use of EverLift in people with Colo-rectal Cancer and Polyp of Colon, run by Stanford University at 1 site in United States.
Trial summary
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer, Polyp of Colon, Adenomatous Polyp of Colon
- What is being tested?
- Use of EverLift and Without use of EverLift
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients 18 years or older
- Polyps 4-9mm
Who cannot join
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Palo Alto Health Care System
Palo Alto, California, 94304
About this study
Official title: Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
Read the detailed description
The details of the proposed study are as follows:
- Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
- Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
- Methods:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
- If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
- After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
- The polyp as well as well as the two biopsies are reviewed by a pathologist.
- Being tested
- Use of EverLift, Without use of EverLift
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of EverLiftDevice
Use of EverLift for submucosal injection prior to polypectomy
Without use of EverLiftDevice
Without use of EverLift for submucosal injection prior to polypectomy
| Study group | Role | What they receive |
|---|---|---|
| With EverLift | Experimental | Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. Receives: Device: Use of EverLift |
| Without EverLift | Experimental | Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. Receives: Device: Without use of EverLift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Polyps With Complete Resection
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
Measured: 2 weeks
Secondary outcomes (3)
Time to Resection
The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.
Measured: During the procedure
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
Measured: During the procedure (up to 10 minutes)
Number of Patients With Procedural Complications
Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.
Measured: 4 weeks (from procedure through 30 day follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start16 Sep 2020
- Primary completion31 May 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shai Friedland, Stanford University
- Investigators
- Shai Friedland, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551014
- Sponsor's protocol ID
- 15766-2
- Status last verified
- Aug 2022
- First submitted
- 9 Sep 2020
- Last updated
- 1 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Investigating Use of Submucosal Injection of EverLift in Rates of Complete Resection of Nonpedunculated Polyps 4-9mm
- ClinicalTrials.gov ID
- NCT04551014
- Acronym / sponsor ID
- 15766-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 1 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
Detailed description
The details of the proposed study are as follows:
- Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
- Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
- Methods:
- Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
- If polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of EverLift.
- After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
- The polyp as well as well as the two biopsies are reviewed by a pathologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With EverLift | Experimental | Device: Use of EverLiftPolypectomy performed for polyps 4-9mm with submucosal injection of EverLift. |
| Without EverLift | Experimental | Device: Without use of EverLiftPolypectomy performed for polyps 4-9mm without submucosal injection of EverLift. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older
- Polyps 4-9mm
Key exclusion criteria (3 listed)
- Pregnant
- Inflammatory bowel disease
- Polyposis syndromes
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 |
|---|---|---|
| Use of EverLiftUse of EverLift for submucosal injection prior to polypectomy | Device | With EverLift |
| Without use of EverLiftWithout use of EverLift for submucosal injection prior to polypectomy | Device | Without EverLift |
Primary outcome
Number of Polyps With Complete Resection
Time frame: 2 weeks
The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.
3 secondary outcomes
Time to Resection
Time frame: During the procedure
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.
Time frame: During the procedure (up to 10 minutes)
Number of Patients With Procedural Complications
Time frame: 4 weeks (from procedure through 30 day follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shai Friedland, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of EverLift and Without use of EverLift in people with Colo-rectal Cancer and Polyp of Colon, run by Stanford University 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 1 Sep 2022. 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?
Yes. Results are posted in the registry (first posted 1 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Polyps With Complete Resection (time frame: 2 weeks). 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 1 Sep 2022.