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Sponsored by: |
Light Sciences Oncology |
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Information provided by: | Light Sciences Oncology |
ClinicalTrials.gov Identifier: | NCT00709488 |
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).
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms |
Drug: Talaporfin sodium Procedure: Placement of device in prostate urethra Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy |
Estimated Enrollment: | 12 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Litx™ BPH Therapy: Experimental |
Drug: Talaporfin sodium
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Procedure: Placement of device in prostate urethra
Placement of device in prostate urethra
Device: Transurethral illumination with light emitting diodes (Litx™ BPH Device)
Patients in Cohort A will receive 50 J of light treatment with 1 mg/kg LS11 administration and patients in Cohort B will receive 70 J of light treatment with 1 mg/kg LS11 administration.
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The eligible patients will be enrolled into one of the two Litx™ treatment Cohorts (A or B)
All patients will undergo the procedure of Litx™ BPH Device placement into the prostate urethra.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort A will be administered an intravenous dose of LS11 (talaporfin sodium) at 1 mg/kg by slow push over 3 - 5 minutes. Fifteen minutes after injection, each patient will be administered a 50 J total light dose, delivered at 20 mW/cm over a 42 minute time period.
Following the placement of the Litx™ BPH Device into the urethra, patients in Cohort B will receive LS11 intravenously at 1 mg/kg by slow push over 3 to 5 minutes. The light activation procedure is the same as that for Cohort A except that a light dose of 70 J will be delivered to each patient over a 58 minute time period.
After 30 days, patients who have not experienced an improvement in symptoms, as determined by the investigator, may undergo an additional interventional therapy with continued follow-up per the protocol.
At the end of 4 weeks following treatment of the last patient in Cohort A, the number of patients requiring surgical intervention for relief of primary symptoms will be assessed for futility of the current protocol prior to commencing with treatment of the first patient in Cohort B.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Urological Sciences Research Foundation | Recruiting |
Culver City, California, United States, 90232 | |
Contact: Malu Macairan 310-838-6347 | |
Principal Investigator: Leonard S Marks, MD | |
United States, Oregon | |
The Portland Clinic | Recruiting |
Portland, Oregon, United States, 97205 | |
Contact: Susan Stindt 503-221-0161 ext 2109 | |
Principal Investigator: Ehud Zusman, MD | |
United States, Washington | |
Integrity Medical Research | Recruiting |
Mountlake Terrace, Washington, United States, 98043 | |
Contact: Somar Macek 425-275-0680 | |
Principal Investigator: Karny Jacoby, MD | |
Seattle Urological Associates | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Jenni Gallagher 206-838-1638 | |
Contact: Angie Sievers | |
Principal Investigator: Erik Torgerson, MD |
Study Director: | Sy-Shi Wang, PhD | Light Sciences Oncology, Inc. |
Responsible Party: | Light Sciences Oncology, Inc. ( Sy-Shi Wang/Study Director ) |
Study ID Numbers: | LSO-OL008 |
Study First Received: | June 30, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00709488 |
Health Authority: | United States: Food and Drug Administration |
Litx™ BPH System LS11 Talaporfin sodium |
Hyperplasia Talaporfin Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Photosensitizing Agents Pathologic Processes Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |