Clinical trial NCT06668142: A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Official title: A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: HoLEP
RoLEP
Robotic HoLEP
BPH
Prostate
urology
robotic
Andromeda
ASTRA
Lead sponsor: Andromeda Surgical
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 54
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Robotic assisted surgery for benign prostatic hyperplasia (BPH)

Detailed description: A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.

Eligibility criteria: Inclusion Criteria:

1. Male
2. Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
3. Subject is able and willing to comply with all the assessments of the study,
4. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
5. ≥ 45 years of Age,
6. Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
7. The subject is indicated for undergoing HoLEP procedure

Exclusion Criteria:

1. Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
2. History of prostate cancer or current/suspected bladder cancer,
3. Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
4. History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
5. Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
6. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
7. Previous pelvic irradiation or radical pelvic surgery,
8. Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
9. Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),
10. Any severe illness that would prevent complete study participation or confound study results.
11. Bleeding tendency disorders,
12. Future fertility concerns,
13. Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
14. Concomitant participation in another interventional study

Primary outcomes:
measure: Number of Participants Successfully Completing Robot-Assisted HoLEP (Enucleation and Morcellation) Without Conversion
timeFrame: During the procedure.
measure: Number of subjects with adverse events ( Clavien-Dindo Grade 3a or higher )
timeFrame: From procedure date to 30 days
Secondary outcomes:
measure: Number of Participants with Capsular Perforation Leading to Procedure Interruption or Conversion
timeFrame: From procedure date to 30 days.
measure: Number of Participants with Bladder Perforation Leading to Procedure Interruption or Conversion
timeFrame: From procedure date to 30 days.
measure: Number of Participants with Ureteric Orifice Damage Requiring Intervention
timeFrame: From procedure date to 30 days.
measure: Length of Hospital Stay Post-Procedure
timeFrame: From procedure date to 30 days
measure: Length of Catheterization Post-Procedure
timeFrame: From procedure date to 30 days
measure: Operative Time for Procedure Completion
timeFrame: During the procedure.
measure: Number of Participants with Repeat Hospitalization for Genitourinary Conditions
timeFrame: From procedure date to 30 days post-procedure.
Other outcomes:
measure: Duration of Enucleation and Morcellation Phases
timeFrame: During the procedure.
measure: Number of Participants Requiring Blood Transfusion Post-Procedure
timeFrame: From procedure date to 30 days.
measure: Number of Participants Requiring Secondary Reintervention with HoLEP or Alternative Surgical Therapy
timeFrame: From procedure date to 30 days.
measure: Incidence Rate of Stress Urinary Incontinence Post-Procedure
timeFrame: From procedure date to 30 days.
Locations:
city: Santiago
country: Chile
facility: Universidad Catolica de Chile
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital Clínico de la Universidad de Chile
state: Región Metropolitana
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research Limited
Study officials:
affiliation: Tauranga urology research
name: Peter Gilling, MD, FRACS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chile Clinical Hospital
name: Rodrigo Ledezma, MD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shvero A, Kloniecke E, Capella C, Das AK. HoLEP techniques - lessons learned. Can J Urol. 2021 Aug;28(S2):11-16.
citation: Abedi A, Razzaghi MR, Rahavian A, Hazrati E, Aliakbari F, Vahedisoraki V, Allameh F. Is Holmium Laser Enucleation of the Prostate a Good Surgical Alternative in Benign Prostatic Hyperplasia Management? A Review Article. J Lasers Med Sci. 2020 Spring;11(2):197-203. doi: 10.34172/jlms.2020.33. Epub 2020 Mar 15.
citation: Das AK, Han TM, Hardacker TJ. Holmium laser enucleation of the prostate (HoLEP): size-independent gold standard for surgical management of benign prostatic hyperplasia. Can J Urol. 2020 Aug;27(S3):44-50.
citation: Das AK, Teplitsky S, Humphreys MR. Holmium laser enucleation of the prostate (HoLEP): a review and update. Can J Urol. 2019 Aug;26(4 Suppl 1):13-19.