Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
31. juli 2026 opdateret af: Alex Qinyang Liu, Chinese University of Hong Kong
Prospective, Single-Site, Single-Arm Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
Prospective, single-arm, single-site, post-market device study; all procedures use Veloxion™ per IFU.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
The aim of the study is to prospectively evaluate the operational efficiency and safety of the Veloxion™ disposable resectoscope system when used for endoscopic surgical treatment of benign prostatic hyperplasia.
Subjects will be followed up on 2 weeks (phone/clinic) and 1 month, (phone/clinic, safety assessments, device-related AEs, reinterventions, usability feedback).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Alex Qinyang LIU, MBBS, MSc, FRCSEd
- Telefonnummer: +852-3505-2625
- E-mail: alexliu@surgery.cuhk.edu.hk
Undersøgelse Kontakt Backup
- Navn: Chi Fai NG, MBChB, MD, FRCSEd
- Telefonnummer: +852-3505-2625
- E-mail: ngcf@surgery.cuhk.edu.hk
Studiesteder
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Shatin, Hong Kong
- Prince of Wales Hospital
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Kontakt:
- Qinyang LIU, MBBS, MSc, FRCSEd
- Telefonnummer: +852-3505-2625
- E-mail: alexliu@surgery.cuhk.edu.hk
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-
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:
- Age 30-70 years old with symptomatic BPH.
- Prostate volume 20-120 mL (TRUS/MRI/US)
- Suitable for endoscopic resection/vaporization per device IFU.
- Able to consent and comply with follow-up to 1 month.
Exclusion Criteria:
- Known/suspected prostate cancer requiring oncologic management.
- Prior prostate surgery impacting urethral anatomy within 12 months.
- Prior implant affecting urethral anatomy.
- Active UTI or untreated bacteriuria pre-op.
- Uncorrectable coagulopathy; inability to manage antithrombotics.
- Severe medical comorbidity precluding anesthesia or endoscopy.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Aulea Veloxion™ Disposable Resectoscope System
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TURP will be performed by Aulea Veloxion™ Disposable Resectoscope System.
The resectoscopes are single-use and ensure consistent quality and no cross-contamination.
The automated fluid management system continuously monitors and manages intravesical pressure while actively evacuating tissue to prevent clogging.
The active power generation system optimize plasma generation for effective resection and extended equipment life.
This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner.
This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
Veloxion™ platform disposable resectoscope is FDA-cleared for treatment of BPH.
It is an all-in-one, platform that combines fluid control, video pipeline and energy generator.
The resectoscopes are single-use and ensure consistent quality and no cross-contamination.
The automated fluid management system continuously monitors and manages intravesical pressure while actively evacuating tissue to prevent clogging.
The active power generation system optimize plasma generation for effective resection and extended equipment life.
This system allows transurethral resection of prostate to be performed in a motorized and highly effective manner.
This study is designed to prospectively characterize operational efficiency in real-world BPH resections using the cleared device platform.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in total procedure time versus a pre-specified benchmark
Tidsramme: Perioperative
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Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
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Perioperative
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Difference in case cost versus a pre-specified benchmark
Tidsramme: Perioperative
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Derived from historical standard reusable resectoscope TURP/TURP-like procedures at the same site, tested against a superiority margin
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Perioperative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Resection time
Tidsramme: Intra-operative
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The cumulative electrosurgery activation time (minutes) from generator logs and video annotation.
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Intra-operative
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The Instrument exchanges time
Tidsramme: Intra-operative
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The count and cumulative time with scope out-of-field; standardized categories (loop, electrode, sheath, camera).
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Intra-operative
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The Visibility score
Tidsramme: Intra-operative
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Assessed by the surgeon-rated 5-point Likert per 15-minute epoch; total irrigation volume; number of bag exchanges; "red-out" events.
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Intra-operative
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Adverse event
Tidsramme: Within post-operative 30 days
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By "Clavien-Dindo Classification"
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Within post-operative 30 days
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The cost per case
Tidsramme: Intra-operative
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equipment, facility, consumables, device, reprocessing, repair, maintenance, rental (if applicable), staff cost to perform the surgery
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Intra-operative
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Staff usability scores
Tidsramme: Intra-operative
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By OR nurse and scrub tech 5-point Likert for setup ease, troubleshooting, case flow.
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Intra-operative
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Total procedure time
Tidsramme: intra-operative
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The time from scope insertion to final scope removal (minutes) from OR time logs/video time stamps.
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intra-operative
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Qinyang LIU, MBBS, MSc, FRCSEd, Chinese University of Hong Kong
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 (Anslået)
16. juli 2026
Primær færdiggørelse (Anslået)
30. juni 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
16. juli 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
27. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRE-2026.117
Plan for individuelle deltagerdata (IPD)
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Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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