Status:
COMPLETED
Phase 1 Study of the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Light Sciences Oncology
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1 study to evaluate the safety and effectiveness of using the Litx™ BPH System in patients with LUTS due to benign prostatic hyperplasia (BPH).
Detailed Description
The eligible patients will be enrolled into one of the three Litx™ treatment Cohorts (A, B or C) All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra. Foll...
Eligibility Criteria
Inclusion
- Males, 50 years or older, who are on an alpha blocker and/or a 5-alpha reductase inhibitor or a combination, and are candidates for interventional therapy. Patients to continue on an alpha blocker and/or 5-alpha reductase inhibitor for at least one-month after the Litx™ treatment, then tapered off medication at physician's discretion.
- Patients who understand and have the ability to sign written informed consent prior to any study procedures and discontinuation of exclusionary medications.
- Patients with moderate to severe BPH bother score \>3 requiring non-medication intervention.
- Patients with an IPSS1 Score of \>15 points.
- Maximum urinary flow rate (Qmax) ≤15 mL/sec.
- Post void residual volume (PVR) ≤300 mL.
- Prostatic volume \>50g by TRUS.
Exclusion
- Patients with any previous minimally invasive or surgical intervention for BPH.
- Patients who have enrolled, or are currently enrolled in, another clinical trial for any disease within the past 30 days.
- Patients with an active urinary tract infection.
- Patients with a urethral stricture.
- Patients with a predominant middle lobe obstruction.
- Patients who have evidence or history of prostate or bladder cancer.
- Patients with a PSA of \>10 ng/ml. If the PSA is 4-10 ng/ml, preliminary biopsy should be done within one-year prior to entry into the study to rule out prostate cancer.
- Patients who had a biopsy of the prostate within the past 6 weeks.
- Patients with bleeding diathesis.
- Patients with clinically significant renal or hepatic impairment.
- Patients with neurological conditions felt to affect the bladder or a history of a neurogenic or chronically decompensated bladder.
- Patients who daily use a pad or device for incontinence.
- Patients who had an episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriches syndrome.
- Patient has an interest in future fertility.
- Patients with prolonged QT interval at baseline or currently taking medications that prolong QT interval (prolonged QT interval defined as \> 450 ms).
- Inadequate organ function as evidenced by the following: Platelet count \<100,000/mm³; WBC \<4,000/mm³; Neutrophils \<1,800/mm³; Hemoglobin \<10 g/dL; SGOT and SGPT \>3 x ULN; Creatinine \>1.2 mg/dL
- Known sensitivity to porphyrin-type drugs or known history of porphyria.
- Known sensitivity to antibiotics (i.e., levofloxacin, gentamicin, etc.).
- Inability to avoid sunlight after procedure during the first 2 weeks after LS11 administration.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00709488
Start Date
June 1 2008
End Date
April 1 2011
Last Update
November 16 2012
Active Locations (6)
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1
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
2
UCLA School of Medicine, GU Clinical Trials Office
Los Angeles, California, United States, 90095
3
The Portland Clinic
Portland, Oregon, United States, 97205
4
Urology San Antonio Research
San Antonio, Texas, United States, 78229