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

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400980
• Other study ID #: CP002
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: January 2027

Study information

• Verified date: May 2023
• Source: Prodeon Medical, Inc
• Contact: Clinical Department
• Phone: 6694671100
• Email: clinical[@]prodeonmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2027
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Subject has signed an informed consent form (ICF).

2. Men = 45 years.

3. 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.

4. Prostate volume 30-80 cc.

5. 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:

1. Previous BPH procedure intended to disobstruct the bladder outlet.

2. Obstructive protruding (mobile) middle (median) prostatic lobe.

3. High bladder neck.

4. Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.

5. Biopsy of the prostate within past 8 weeks.

6. Confirmed or suspected bladder cancer.

7. 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).

8. History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.

9. History of neurogenic bladder.

10. Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).

11. Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention.

12. Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).

13. 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).

14. Active infection including acute bacterial prostatitis.

15. Previous pelvic irradiation or radical pelvic surgery.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Urocross implant
Urocross implant inserted via delivery catheter

Diagnostic Test:
• Sham-control
Cystoscopy

Locations

Country	Name	City	State
United States	Prisma Health	Columbia	South Carolina
United States	Loyola University Medical Center	Maywood	Illinois
United States	Urology Associates of Silicon Valley	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Prodeon Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Urocross Expander Implant	The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.	more than 7 days post procedure
Primary	Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath	Mean improvement in Total IPSS at 3 months vs baseline	3 month post procedure
Secondary	Percent change in Total IPSS	Percent change in Total IPSS from baseline to 12 months post-retrieval for subjects randomized to the Urocross Implant group	12 Month post implant retrieval