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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypectomy | Experimental | When a 6-25mm polyp is identified the Tandem snare will be inserted through the colonoscope, remove and retrieve the polyp. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tandem Snare | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Device related major adverse events | Device related major adverse events include death, major bleeding or perforation) | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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, | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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