Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2023-12-01
2025-04-02
Brief Summary
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Detailed Description
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The safety profile will be documented by collecting data on frequency and severity of complications, AEs such as bleeding and perforations.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Multi4 procedure
Complete TURBT procedure performed in local anesthesia with Multi4 instrument via flexible cystoscopy
Multi4
TURBT procedure performed with the Multi4 instrument in local anesthesia
Interventions
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Multi4
TURBT procedure performed with the Multi4 instrument in local anesthesia
Eligibility Criteria
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Inclusion Criteria
* Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible at cystoscopy, estimated size \< 10 mm
* Willingness and ability to provide informed consent
* Age ≥18 years
Exclusion Criteria
* Current/ongoing untreated urinary tract infection
* Pregnancy or breastfeeding
* Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation
18 Years
ALL
No
Sponsors
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Key2Compliance
INDUSTRY
Multi4 Medical Ab
INDUSTRY
Responsible Party
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Principal Investigators
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Henrik Kjölhede, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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CI-02-23-0002
Identifier Type: -
Identifier Source: org_study_id
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