The Expander-2 Trial: A Randomized Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

Sponsor

Prodeon Medical, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05400980

Collaborator

(none)

240

Enrollment

Locations

Arms

53.9

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: Urocross implant Diagnostic Test: Sham-control	N/A

Detailed Description

Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).

Primary Purpose:

Treatment

Official Title:

The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

Actual Study Start Date :

Jul 5, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urocross implant group The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.	Device: Urocross implant Urocross implant inserted via delivery catheter
Sham Comparator: Sham-control group The sham-control in this trial is cystoscopy only.	Diagnostic Test: Sham-control Cystoscopy

Arm

Intervention/Treatment

Experimental: Urocross implant group

The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.

Device: Urocross implant

Urocross implant inserted via delivery catheter

Sham Comparator: Sham-control group

The sham-control in this trial is cystoscopy only.

Diagnostic Test: Sham-control

Cystoscopy

Outcome Measures

Primary Outcome Measures

Safety of Urocross Expander Implant [more than 7 days post procedure]
The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.
Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath [3 month post procedure]
Mean improvement in Total IPSS at 3 months vs baseline

Secondary Outcome Measures

Percent change in Total IPSS [12 Month post implant retrieval]
Percent change in Total IPSS from baseline to 12 months post-retrieval for subjects randomized to the Urocross Implant group

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject has signed an informed consent form (ICF).
Men ≥ 45 years.
Symptomatic BPH with the following (all must be met):

IPSS ≥ 13.
Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL.
PVR < 250 mL.

Prostate volume 30-80 cc.
Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day.

Exclusion Criteria:

Subjects who meet ANY of the following exclusion criteria will not participate in the trial:

Previous BPH procedure intended to disobstruct the bladder outlet.
Obstructive protruding (mobile) middle (median) prostatic lobe.
High bladder neck.
Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
Biopsy of the prostate within past 8 weeks.
Confirmed or suspected bladder cancer.
Confirmed or suspected prostate cancer. Note: Subjects with suspected prostate cancer with a Prostate Specific Antigen (PSA) level > 2.5 ng/mL and ≤ 10 ng/mL with their free PSA < 25% of total PSA, must undergo a biopsy to rule out the diagnosis of prostate cancer. If biopsy is performed, and subject has no cancer, a waiting period of 8 weeks is required prior to randomization (see exclusion criterion 7).
History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
History of neurogenic bladder.
Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention.
Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).
Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a negative urine culture), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).
Active infection including acute bacterial prostatitis.
Previous pelvic irradiation or radical pelvic surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Associates of Silicon Valley	San Jose	California	United States	95124
2	Loyola University Medical Center	Maywood	Illinois	United States	60153
3	Prisma Health	Columbia	South Carolina	United States	29203