CompletedNot Applicable

Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue

Panama32 participantsStarted 2022-11-14

Plain-language summary

This goal of this clinical trial is to determine if the Vanquish System can safely and effectively treat cancerous tissue in the prostate. Researchers will also determine the best treatment dose, monitor safety during and immediately after the procedure, and examine prostate tissue after surgical removal to confirm how well the treatment destroyed targeted tissue. Patients enrolled have been diagnosed with prostate cancer and will undergo treatment with the Vanquish System before their scheduled radical prostatectomy.

Who can participate

Age range40 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is 40 years or older * Subjects is diagnosed with clinically localized prostate cancer (Stage I (T1c) or Stage II (T2a, T2b, T2c tumor) prostate cancer) AND scheduled for a radical prostatectomy or cystoprostatectomy due to the presence of prostate cancer * Subject has a positive biopsy for prostate cancer with Gleason score of 8 (4+4) and below * Subject who provides written consent to participate in the study Exclusion Criteria: * Subject with prostate biopsy performed within 42 days from date of prostatectomy. * Subject has a known allergy to nickel. * Subject who had previous rectal surgery (other than hemorrhoidectomy) * Subject with known history of rectal disease. * Subject currently participating in other premarket investigational studies. * Subject who had a previous TURP or prostatectomy.

What they're measuring

Lesion Characterization by Location and Thermal Damage

Timeframe: Evaluated immediately post procedure.

Trial details

NCT IDNCT07561502

SponsorFrancis Medical Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-11