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| Name | Class |
|---|---|
| Key2Compliance | INDUSTRY |
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A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions
The overall purpose of this study is to confirm performance and safety of Multi4 Medical Device System when used as intended: to cauterize, remove, and automatically collect multiple tissue samples through the working channel of an endoscope.
The safety profile will be documented by collecting data on frequency and severity of complications, AEs such as bleeding and perforations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi4 procedure | Experimental | Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi4 | Device | TURBT procedure performed with the Multi4 instrument in local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluable biopsies | Biopsies collected by the instrument are evaluable by pathologist | At procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Frequency and severity of adverse events related to instrument use | One week |
| Number of patients with complete procedures performed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Kjölhede, MD PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Proportion of procedures that can be completely performed with the instrument
| At procedure |
| Patient-reported treatment-related pain (numeric rating scale) | Patient reported pain experienced during procedure, from 0 (no pain) to 10 (worst possible pain) | At procedure |
| Quality of life (EQ-5D-5L) | Difference in self reported quality of life with the EuroQol 5-level instrument, prior to procedure compared to one week after procedure | At procedure and after 1 week |
| Time to perform procedure | Time taken to perform a complete procedure | At procedure |
| Time for patient surveillance | Time taken for observation after procedure | At procedure |
| Self reported satisfaction with procedure | Proportion of patients who, in case of further bladder cancer recurrences, would choose to undergo the same procedure in local anesthesia as opposed to a full TURBT in general anesthesia | One week |
| Operator-reported ease of use | Number of procedures where to operator reports that the Multi4 instrument works without issue and is easily handled (yes), or whether there are handling issues (no) | At procedure |
| Cost effectiveness | Total costs associated with procedure compared to a complete TURBT in general anesthesia | At procedure |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |