PolypsNCT02754050
Safety and Feasibility of the Tandem Snare Device
A study testing Tandem Snare in people with Polyps, run by Tandem Technologies LTD.
Trial summary
The device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polyps
- What is being tested?
- Tandem Snare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Oct 2018
- 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
- Adults > 18 Years
- Subjects have been scheduled for colonoscopy
- Subject has signed the informed consent
Who cannot join
- Suspected or known active Inflammatory Bowel Disease (IBD)
- Coagulopathy or thrombocytopenia.
- Taking dual anti platelet therapy or anti coagulants.
- Bowel preparation is deemed poor by colonoscopist.
- Subjects with known or detected (during colonoscopy) moderate/severe diverticular disease.
- History of familial polyposis (FAP).
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- History of prior surgery to colon and/or rectum.
- ASA ≥ IV.
- Pregnancy (as stated by patient).
- Subjects with altered mental status/inability to provide informed consent.
- Patients who have participated in another interventional clinical study in the last month.
- Subject under a condition which in the investigators opinion may put the subject at significant risk, confound study results, or interfere significantly.
About this study
The device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.
Read the detailed description
The colonoscopy procedure is considered the "gold standard" for detecting, diagnosing and treating abnormalities in the colon. Detection and removal of colon polyps is the most significant benefit colonoscopy provides toward the reduction of colorectal cancer mortality and morbidity. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. The technology may eliminate the repeated bites with the intervention tool or the need to use additional intervention tools such as the net. It may improve visual perception for resecting the polyp without losing it while removing from the colon. Consequently it may increase the potential for complete polypectomy and reduce intervention time and repetitions, polyp lost, risks and cost. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.
- Conditions
- Polyps
- Being tested
- Tandem Snare
- Medical subject headings
- Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem SnareDevice
| Study group | Role | What they receive |
|---|---|---|
| Polypectomy | Experimental | When a 6-25mm polyp is identified the Tandem snare will be inserted through the colonoscope, remove and retrieve the polyp. Receives: Device: Tandem Snare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related major adverse events
Device related major adverse events include death, major bleeding or perforation)
Measured: 7 days
Technical success of the Tandem Snare.
The primary feasibility assessment will be encountered as success if the Tandem Snare was inserted through the working channel, cut the polyp and the device was successfully removed from the working channel.
Measured: 1 day
Secondary outcomes (1)
Retrieval rate of the polyps that have been cut by the Tandem Snare.
The secondary performance assessment will be based on data from all polyps which were resected by the Tandem Snare. Retrieval of the resected polyp will be encountered as success,
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tandem Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754050
- Sponsor's protocol ID
- CP-001
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of the Tandem Snare Device
- ClinicalTrials.gov ID
- NCT02754050
- Acronym / sponsor ID
- CP-001
- Conditions
- Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tandem Technologies LTDIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 28 Apr 2016 (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 device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.
Detailed description
The colonoscopy procedure is considered the "gold standard" for detecting, diagnosing and treating abnormalities in the colon. Detection and removal of colon polyps is the most significant benefit colonoscopy provides toward the reduction of colorectal cancer mortality and morbidity. The Tandem Snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. The Tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. The technology may eliminate the repeated bites with the intervention tool or the need to use additional intervention tools such as the net. It may improve visual perception for resecting the polyp without losing it while removing from the colon. Consequently it may increase the potential for complete polypectomy and reduce intervention time and repetitions, polyp lost, risks and cost. This is a feasibility study aiming to demonstrate the safety of the Tandem Snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polypectomy | Experimental | Device: Tandem SnareWhen a 6-25mm polyp is identified the Tandem snare will be inserted through the colonoscope, remove and retrieve the polyp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > 18 Years
- Subjects have been scheduled for colonoscopy
- Subject has signed the informed consent
Key exclusion criteria (12 listed)
- Suspected or known active Inflammatory Bowel Disease (IBD)
- Coagulopathy or thrombocytopenia.
- Taking dual anti platelet therapy or anti coagulants.
- Bowel preparation is deemed poor by colonoscopist.
- Subjects with known or detected (during colonoscopy) moderate/severe diverticular disease.
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 |
|---|---|---|
| Tandem Snare | Device | Polypectomy |
Primary outcome
Device related major adverse events
Time frame: 7 days
Device related major adverse events include death, major bleeding or perforation)
Technical success of the Tandem Snare.
Time frame: 1 day
The primary feasibility assessment will be encountered as success if the Tandem Snare was inserted through the working channel, cut the polyp and the device was successfully removed from the working channel.
1 secondary outcome
Retrieval rate of the polyps that have been cut by the Tandem Snare.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tandem Snare in people with Polyps, run by Tandem Technologies LTD.
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 12 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: status not confirmed, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Device related major adverse events (time frame: 7 days). The study lists 2 primary outcomes in all. 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 28 Apr 2016.