Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (PERI III)
24. april 2026 opdateret af: Francis Medical Inc.
Transurethral Periprostatectomy Treatment of Cancerous Prostate Tissue (Peri III Study)
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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Provincia de Panamá
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Panama City, Provincia de Panamá, Panama, 0801
- C&M Research S.A.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment with Vanquish System
|
Water vapor ablation delivered transurethrally in patients undergoing a radical prostatectomy for prostate cancer.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Lesion Characterization by Location and Thermal Damage
Tidsramme: Evaluated immediately post procedure.
|
The primary efficacy endpoint is a lesion characterization from the Peri III Study vapor treatment as evaluated by TTC stain.
Immediately following treatment and surgical extirpation, the prostate was examined for any external thermal injury followed by whole mount sectioning and staining using tetrazolium chloride (TTC).
The whole mount sections were photographed before and after TTC staining.
The sections and photographs were examined for ablation within all anatomic regions of the prostate and the ability to ablate to different regions and zones of the prostate.
|
Evaluated immediately post procedure.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adequacy Scale to Measure Visualization During Procedure
Tidsramme: From the beginning to the end of the treatment procedure.
|
Visualization during the procedure is important to ensure proper placement of the needle.
Ultrasound was evaluated for visualization and graded by operator.
Visualization adequacy was assessed in real time by the physician using a categorical scale (adequate/somewhat adequate/inadequate), based on subjective evaluation of target and instrument visibility on the ultrasound image.
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From the beginning to the end of the treatment procedure.
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Safety Measurements
Tidsramme: Through 30 days following procedure.
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Any procedure-related AEs were collected and reported through 30 days.
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Through 30 days following procedure.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2022
Primær færdiggørelse (Faktiske)
11. august 2023
Studieafslutning (Faktiske)
11. august 2023
Datoer for studieregistrering
Først indsendt
17. april 2026
Først indsendt, der opfyldte QC-kriterier
24. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3838-012
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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