RecruitingACTRN12609000760279

Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra: A Preliminary Investigation

Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra in males with benign prostatic hyperplasia: A Preliminary Investigation

Sponsor

NeoTract, Inc.

Enrollment

70 participants

Start Date

Dec 5, 2005

Study Type

Interventional

Conditions

Benign Prostatic Hyperplasia (BPH)

Summary

Luminal restoration of the prostatic urethra involves implanting the NeoTract Anchor System, which is designed to hold back the lobes of the prostate, and open the urethra (the tube that carries urine from your bladder to the outside of your body) to relieve symptoms associated with urinary obstruction. This study is a prospective, open-label feasibility study enrolling up to 70 participants. Safety and feasibility are the primary endpoints while patient questionnaires and therapeutic effectiveness is assessed as a secondary endpoint. Follow-up visits are at 24 hours, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year, and annually thereafter for the 7 year duration

Eligibility

Sex: MalesMin Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new minimally invasive procedure for men with an enlarged prostate (benign prostatic hyperplasia, or BPH) that is causing urinary problems. The procedure uses a device called the NeoTract Anchor System, which is inserted through the urethra (the tube that carries urine from the bladder) and holds back the enlarged prostate lobes to widen the urinary passage. This is different from traditional prostate surgery because no tissue is removed or burned. The study will track whether this approach safely improves urinary flow and reduces symptoms over 7 years. You may be eligible if: - You are a male aged 55 years or older - You have been diagnosed with BPH causing lateral lobe obstruction - Your urinary symptom score (IPSS) is greater than 13 - Your urine flow rate is between 5 and 12 mL/sec - Your prostate is between 20 and 100 grams in size - Your PSA has been stable over 2 years You may NOT be eligible if: - You have had previous prostate surgery or non-medication prostate treatments - You have a history of urinary retention - Your post-void residual urine is above 250 mL - You have a PSA above 10 ng/mL - You have bladder, prostate, or urethral conditions that affect voiding - You are on anticoagulant medications (other than aspirin or clopidogrel) - You are interested in future fertility Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The NeoTract Anchor System is a mechanical device that is designed to hold back the lobes of the prostate and relieve symptoms associated with urinary obstruction. The device is delivered transurethr

The NeoTract Anchor System is a mechanical device that is designed to hold back the lobes of the prostate and relieve symptoms associated with urinary obstruction. The device is delivered transurethrally under endoscopic guidance. The procedure duration is usually 90 minutes or less. Once implanted, the device remains permanently in place.