Trial record 1 of 1 for:
05683691
Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer (VAPOR 2)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05683691 |
Recruitment Status :
Recruiting
First Posted : January 13, 2023
Last Update Posted : May 20, 2024
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Sponsor:
Francis Medical Inc.
Information provided by (Responsible Party):
Francis Medical Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 5, 2023 | ||||||||
First Posted Date ICMJE | January 13, 2023 | ||||||||
Last Update Posted Date | May 20, 2024 | ||||||||
Actual Study Start Date ICMJE | May 16, 2023 | ||||||||
Estimated Primary Completion Date | April 2027 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Key Secondary Endpoint [ Time Frame: 36 months ] The proportion of subjects free from impotence.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Water Vapor Ablation for Localized Intermediate Risk Prostate Cancer | ||||||||
Official Title ICMJE | Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR | ||||||||
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Prospective, Multicenter, Single-Arm Study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||
Intervention ICMJE | Device: Vanquish System
Water vapor ablation delivered transurethrally in patients with intermediate risk, localized prostate cancer.
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Study Arms ICMJE | Experimental: Vanquish System Treatment
Intervention: Device: Vanquish System
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
400 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | April 2029 | ||||||||
Estimated Primary Completion Date | April 2027 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05683691 | ||||||||
Other Study ID Numbers ICMJE | 4760-001 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Francis Medical Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Francis Medical Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Francis Medical Inc. | ||||||||
Verification Date | May 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |