Phase 1 Study of the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2011

Study Completion Date

April 30, 2011

Conditions
Benign Prostatic HyperplasiaLower Urinary Tract Symptoms
Interventions
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; patients in Cohort B will receive 70 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort C will receive 100 J of light treatment with 1 mg/kg LS11 administration; patients in Cohort D will receive 100 J of light treatment (with the active light emitting length increased from 10mm to 20 mm) with 1 mg/kg LS11 administration.

Trial Locations (6)

78229

Urology San Antonio Research, San Antonio

90095

UCLA School of Medicine, GU Clinical Trials Office, Los Angeles

97205

The Portland Clinic, Portland

98043

Integrity Medical Research, Mountlake Terrace

98104

Seattle Urological Associates, Seattle

99508

Alaska Clinical Research Center, Anchorage

Sponsors
All Listed Sponsors
lead

Light Sciences Oncology

INDUSTRY