NCT04757116 Post-Market Study to Assess iTind Safety in Comparison to UroLift
| NCT ID | NCT04757116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Olympus Corporation of the Americas |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2022-09-26 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Eligibility Criteria
Inclusion Criteria: 1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended 2. Willing and able to provide informed consent 3. Males ≥ 50 years of age or older 4. PSA \< 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months 5. Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening 6. International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13 7. Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL) 8. Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits Exclusion Criteria: 1. History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months 2. Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer 3. History of acute bacterial prostatitis within the last 2 years 4. Median lobe obstruction of the prostate as confirmed by cross-sectional imaging 5. PSA value \> 10 ng/ml 6. Contraindicated for iTind or UroLift as determined by the PI 7. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function 8. Clinically significant bladder diverticulum 9. Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter 10. Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device 11. An active urinary tract infection during randomization 12. Clinically significant hematuria within the last 3 months or ongoing cystolithiasis 13. Prostate volume \> 75 cc 14. Post-void residual volume (PVR) \> 250 mL 15. Actively using catheterization or unable to void naturally 16. Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure 17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure 18. Known or suspected allergy to nickel, titanium or polyester/polypropylene
Contact & Investigator
Bilal Chughtai, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT04757116 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04757116 currently recruiting?
Yes, NCT04757116 is actively recruiting participants. Contact the research team at Melanie.Bonds@olympus.com for enrollment information.
Where is the NCT04757116 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Fresno, United States, Sacramento, United States and 11 additional locations.
Who is sponsoring the NCT04757116 clinical trial?
NCT04757116 is sponsored by Olympus Corporation of the Americas. The principal investigator is Bilal Chughtai, MD at Northwell Health. The trial plans to enroll 256 participants.