PVP: A Long-Term Study Examining the Treatment of Benign Prostatic Hyperplasia With Photoselective Vaporization

• Sponsor: American Medical Systems (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00465101
• Collaborator: (none)
• Enrollment: 150
• Locations: 9
• Arm: 1
• Duration (Months): 68.1
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: GreenLight HPS	Phase 4

Detailed Description

Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very often, a sudden strong feeling of having to urinate, having to get up at night to urinate, decreased and intermittent force of stream and the feeling of incomplete bladder emptying. These symptoms affect quality of life by interfering with normal daily activities and sleep patterns. When surgery is the best treatment option for the patient, the most common technique is a "transurethral resection of the prostate" (TURP). TURP involves removing the some of the extra tissue of the prostate gland. Even though TURP is a good treatment, there are concerns about the frequency of complications following treatment as well as the significant costs to patients, doctors, and insurance providers.

Photoselective vaporization of the prostate (PVP) is a relatively new technology that has similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area. This technology has been used for more than a decade with over 200,000 procedures performed worldwide.

The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w and 2) to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time, may be done in an out-patient setting in healthy patients, allows for shorter catheterization time, may result in a rapid urinary flow rate with minimal side effects, and may allow a quick return to normal activities. This device has been approved by the United States Food and Drug Administration (FDA) for treatment of obstructive BPH.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Clinical Study for GreenLight HPS in the Treatment of Obstructive Benign Prostatic Hyperplasia (BPH)
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: GreenLight HPS	Device: GreenLight HPS; Greenlight HPS laser system for treatment of BPH

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Treatment Success [6 months]

   Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%

Secondary Outcome Measures

1. Treatment-related Complication [3 months]

   Treatment-related events include the following: Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization Perforation / injury of adjacent organ(s) Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal Hematuria requiring transfusion Urinary retention requiring corrective intervention De novo erectile dysfuction (ED) Transfusion secondary to procedure-related anemia Post procedure incontinence secondary to damage to the external urinary sphincter Any other treatment-related injury requiring intervention

2. Percentage of Participants With Clinically-significant Improvement in Uroflow. [6 months post-treatment]

   A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months

3. Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. [6 months post-treatment]

   A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.

4. Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. [5 years]

   Participant response to the question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Values range from 0 ("Delighted") to 6 ("Terrible") with higher values indicating worse outcomes.

5. Gross Hematuria [91 days]

   Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.

6. Percentage of Participants With Treatment Success [5 Years]

   Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.

7. Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. [Up to five years]

8. Occurrence of Retrograde Ejaculation [5 Year Follow Up]

   Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.

Other Outcome Measures

1. Length of Hospital Stay (LOS) [Peri-Operative Period]

   Defined as the time from admission to the healthcare facility until discharge (in hours).

2. Length of Catheterization (LOC) [Recovery Period]

   Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).

3. Length of Procedure (LOP) [Procedure]

   Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).

4. Length of Lasing (LOL) [Procedure]

   Total time the laser was on during the study procedure.

5. Number of Fibers Used During Procedure [Procedure]

6. Total Joules Used [Procedure]

   Total energy applied during the study procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score >14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) classification of physical status > III

• An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods

• A myocardial infarction or coronary artery stent placement within 6 months of the treatment

• Neurogenic lower urinary dysfunction

• A post-void residual (PVR) volume ≥ 400 mL

• Pre-existing urinary incontinence

• Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function

• Pre-existing damage of external urinary sphincter

• Presence of cystolithiasis, urethral stricture, or bladder neck contracture

• Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc

• Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated

• Immunocompromised subjects

• Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease

• Desire to preserve antegrade ejaculation

• Calcification of prostate tissue, usually after severe prostatitis

• Deemed unfit for laser vaporization as determined by the attending physician

• Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval

• Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	Connecticut Clinical Reseach Center	Middlebury	Connecticut	United States	06762
3	North Fulton Urology, P.C.	Roswell	Georgia	United States	30076
4	Affiliates in Urology	Detroit	Michigan	United States	48186
5	PC Group/Universtiy Urology Association	New York	New York	United States	10016
6	Glickman Urological Institute	Cleveland	Ohio	United States	44195
7	Oklahoma University Health Science Center_Urology	Oklahoma City	Oklahoma	United States	73104
8	UT Southwestern Medical Center at Dallas	Dallas	Texas	United States	75390-9110
9	Urology of Virginia	Virginia Beach	Virginia	United States	23454

Sponsors and Collaborators

• American Medical Systems

Investigators

• Principal Investigator: Claus G Roehrborn, MD, UT Southwestern Medical Center at Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: American Medical Systems
• ClinicalTrials.gov Identifier: NCT00465101
• Other Study ID Numbers: PE0603
• First Posted: Apr 24, 2007
• Last Update Posted: Oct 28, 2015
• Last Verified: Jun 1, 2012

• Keywords provided by American Medical Systems: Benign Prostatic Hyperplasia; Transurethral resection of the prostate; Lower urinary tract symptoms; GreenLight; Laserscope; Photoselective vaporization of the prostate; enlarged prostate
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia

Study Results

Participant Flow

Recruitment Details	This study enrolled patients at least 45 years of age with symptomatic/obstructive BPH for at least 3 months and requiring surgical intervention. Enrollment occurred at 10 academic and private medical centers in the US. The last patient follow up visit was completed in August 2012. The last site close-out visit was completed January 2013.

Arm/Group Title	GreenLight HPS Laser System
Arm/Group Description	GreenLight HPS Laser System therapy for patients with BPH.
Period Title: Overall Study
STARTED	150
COMPLETED	91
NOT COMPLETED	59

Baseline Characteristics

Arm/Group Title	GreenLight HPS Laser System
Arm/Group Description	GreenLight HPS Laser System therapy for patients with BPH.
Overall Participants	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.3 (7.8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	150 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 1.3%
Not Hispanic or Latino	148 98.7%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	150 100%
Height (cm) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	178.5 (7.0)
Weight (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	87.3 (14.8)
Smoker (participants) [Number]
Number [participants]	10 6.7%
Previous BPH Treatment (participants) [Number]
Number [participants]	134 89.3%
Average Duration of Obstructive Symptoms (months) (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	74.9 (60.2)
Peak Flow Rate (ml/sec) (ml/sec) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/sec]	10.7 (5.4)
Post-void Residual Volume (ml) (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	112.5 (115.5)
Serum Prostate Specific Antigen (PSA) level (ng/ml) (ng/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/ml]	2.5 (2.1)
Prostate Volume (cc) (cc) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cc]	58.5 (28.4)
International Prostate Symptom Score (IPSS) at Baseline (Scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Scores on a scale]	22.9 (5.8)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Treatment Success
Description	Treatment success is determined on a per patient basis and is defined as [(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS] greater than or equal to 50%
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	GreenLight HPS Laser System
Arm/Group Description	GreenLight HPS Laser System therapy for patients with BPH.
Measure Participants	119
Number [percentage of participants]	84.9 56.6%

2. Secondary Outcome

Title	Treatment-related Complication
Description	Treatment-related events include the following: Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization Perforation / injury of adjacent organ(s) Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal Hematuria requiring transfusion Urinary retention requiring corrective intervention De novo erectile dysfuction (ED) Transfusion secondary to procedure-related anemia Post procedure incontinence secondary to damage to the external urinary sphincter Any other treatment-related injury requiring intervention
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment.

Arm/Group Title	Treatment Related Complication at 3 Months
Arm/Group Description
Measure Participants	135
Number (95% Confidence Interval) [percentage of subjects with complication]	11.1

3. Secondary Outcome

Title	Percentage of Participants With Clinically-significant Improvement in Uroflow.
Description	A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months
Time Frame	6 months post-treatment

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Number of Subjects With Baseline and 6 Month Values
Arm/Group Description	The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
Measure Participants	117
Number (95% Confidence Interval) [percentage of patients improved]	70.9

4. Secondary Outcome

Title	Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.
Description	A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.
Time Frame	6 months post-treatment

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Number of Subjects With Baseline and 6 Month Values
Arm/Group Description	The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
Measure Participants	117
Number (95% Confidence Interval) [percentage of patients improved]	42.7

5. Secondary Outcome

Title	Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.
Description	Participant response to the question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Values range from 0 ("Delighted") to 6 ("Terrible") with higher values indicating worse outcomes.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Baseline QoL Score	3 Months	6 Months	1 Year	2 Years	3 Years	4 Years	5 Years
Arm/Group Description
Measure Participants	136	131	119	117	103	97	59	4
Mean (Standard Deviation) [Score on a scale]	4.4 (1.1)	1.6 (1.4)	1.3 (1.2)	1.3 (1.2)	1.3 (1.2)	1.3 (1.3)	1.2 (1.2)	0.8 (1.0)

6. Secondary Outcome

Title	Gross Hematuria
Description	Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
Time Frame	91 days

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment

Arm/Group Title	Peri-Operative (0-14 Days)	Delayed (15-91 Days)
Arm/Group Description
Measure Participants	136	136
Number [Percentage of subjects]	1.5	2.2

7. Secondary Outcome

Title	Percentage of Participants With Treatment Success
Description	Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Baseline	3 Months	6 Months	1 Year	2 Years	3 Year	4 Years	5 Years
Arm/Group Description
Measure Participants	136	131	119	117	103	97	59	4
Number (95% Confidence Interval) [Percent of subjects w/ treatment success]	0	72.5	84.9	77.8	79.6	75.3	74.6	100.0

8. Secondary Outcome

Title	Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Time Frame	Up to five years

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Return to Activity (Days)
Arm/Group Description
Measure Participants	126
Mean (Standard Deviation) [days]	9.5 (9.6)

9. Other Pre-specified Outcome

Title	Length of Hospital Stay (LOS)
Description	Defined as the time from admission to the healthcare facility until discharge (in hours).
Time Frame	Peri-Operative Period

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Length of Hospital Stay (Hours)
Arm/Group Description
Measure Participants	135
Mean (Standard Deviation) [hours]	5.2 (7.1)

10. Other Pre-specified Outcome

Title	Length of Catheterization (LOC)
Description	Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).
Time Frame	Recovery Period

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Length of Catheterization
Arm/Group Description
Measure Participants	124
Mean (Standard Deviation) [hours]	21.9 (22.9)

11. Other Pre-specified Outcome

Title	Length of Procedure (LOP)
Description	Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).
Time Frame	Procedure

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Length of Procedure (Min)
Arm/Group Description
Measure Participants	136
Mean (Standard Deviation) [minutes]	53.9 (21.5)

12. Other Pre-specified Outcome

Title	Length of Lasing (LOL)
Description	Total time the laser was on during the study procedure.
Time Frame	Procedure

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Length of Lasing Time
Arm/Group Description
Measure Participants	135
Mean (Standard Deviation) [minutes]	34.1 (17.5)

13. Other Pre-specified Outcome

Title	Number of Fibers Used During Procedure
Time Frame	Procedure

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome is available.

Arm/Group Title	Number of Fibers Used
Arm/Group Description
Measure Participants	136
Mean (Standard Deviation) [number of fibers used]	1.2 (0.5)

14. Other Pre-specified Outcome

Title	Total Joules Used
Description	Total energy applied during the study procedure
Time Frame	Procedure

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment and for whom the outcome measure is available.

Arm/Group Title	Total Energy Delivered
Arm/Group Description
Measure Participants	135
Mean (Standard Deviation) [kilojoules (kJ)]	190.6 (94.4)

15. Secondary Outcome

Title	Occurrence of Retrograde Ejaculation
Description	Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
Time Frame	5 Year Follow Up

Outcome Measure Data

Analysis Population Description

Participants who received the study treatment

Arm/Group Title	Retrograde Ejaculation Occurrence Rate
Arm/Group Description
Measure Participants	136
Number (95% Confidence Interval) [percentage of subjects with RE]	43.3

Adverse Events

Time Frame	Through study completion; planned to be 5 years.
Adverse Event Reporting Description	All participants who received the study treatment will be considered at risk of having an adverse event. This study allowed adverse events to be collected not using specific event terms (e.g., "Other" adverse events).
Arm/Group Title	GreenLight HPS Laser System
Arm/Group Description	GreenLight HPS Laser System therapy for patients with BPH.
All Cause Mortality
	GreenLight HPS Laser System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	GreenLight HPS Laser System
	Affected / at Risk (%)	# Events
Total	35/136 (25.7%)
Blood and lymphatic system disorders
Other: Lymphoma	1/136 (0.7%)	1
Other: Epistaxis	1/136 (0.7%)	1
Cardiac disorders
Other: Atrial Arrhythmia	2/136 (1.5%)	2
Other: Cardiomyopathy	1/136 (0.7%)	1
General disorders
Allergic Reaction / Hypersensitivity	1/136 (0.7%)	1
Injury - Other	1/136 (0.7%)	1
Pain / Discomfort - Other	4/136 (2.9%)	4
Other: Death	2/136 (1.5%)	2
Other	5/136 (3.7%)	8
Infections and infestations
Infection (other than UTI)	1/136 (0.7%)	1
Metabolism and nutrition disorders
Other: Obesity - Worsening	1/136 (0.7%)	1
Musculoskeletal and connective tissue disorders
Pain / Discomfort - Leg	1/136 (0.7%)	1
Other: Hernia	1/136 (0.7%)	1
Other: Multiple Myeloma	1/136 (0.7%)	1
Other: Rotator Cuff Tear	2/136 (1.5%)	2
Other: Knee Replacement	1/136 (0.7%)	1
Renal and urinary disorders
Perforation - Prostate	2/136 (1.5%)	2
Bladder Neck Contracture / Outlet Obstruct	1/136 (0.7%)	1
Hematuria - Gross	1/136 (0.7%)	2
Urinary Retention	1/136 (0.7%)	1
Other: Prostate Cancer	3/136 (2.2%)	3
Other: Renal Failure - Acute	1/136 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Other: Sleep Apnea	1/136 (0.7%)	1
Vascular disorders
Deep Venous Thrombosis	1/136 (0.7%)	1
Other: Coronary Artery Disease	2/136 (1.5%)	3
Other: Stroke	2/136 (1.5%)	2
Other (Not Including Serious) Adverse Events
	GreenLight HPS Laser System
	Affected / at Risk (%)	# Events
Total	97/136 (71.3%)
Cardiac disorders
Other: Hypertension	1/136 (0.7%)	1
Gastrointestinal disorders
Nausea	2/136 (1.5%)	2
Vomiting	1/136 (0.7%)	1
General disorders
Pain / Discomfort - Other	6/136 (4.4%)	6
Allergic Reaction / Hypersensitivity Reaction	1/136 (0.7%)	1
Other	2/136 (1.5%)	2
Renal and urinary disorders
Dysuria	30/136 (22.1%)	31
Retrograde Ejaculation - De Novo	30/136 (22.1%)	30
Urinary Urgency	24/136 (17.6%)	24
Retrograde Ejaculation	23/136 (16.9%)	23
Urinary Frequency	14/136 (10.3%)	15
Urinary Tract Infection (UTI)	9/136 (6.6%)	9
Hematuria	15/136 (11%)	15
Hematuria - Gross	9/136 (6.6%)	10
Erectile Dysfunction - De Novo	8/136 (5.9%)	8
Urinary Incontinence - De Novo	10/136 (7.4%)	10
Bladder Neck Contracture / Outlet Obstruct	4/136 (2.9%)	6
Prostatitis	5/136 (3.7%)	5
Urinary Retention - Acute	2/136 (1.5%)	2
Urinary Retention	2/136 (1.5%)	2
Erectile Dysfunction - Worsening	1/136 (0.7%)	1
Perforation - Prostate	2/136 (1.5%)	2
Sloughing	1/136 (0.7%)	1
Urethral Stricture	1/136 (0.7%)	1
Other: Nocturia	4/136 (2.9%)	4
Other: Urinary Dribbling	6/136 (4.4%)	7
Other: Bladder Spasm	3/136 (2.2%)	3
Other: Lack of Sensation During Ejaculation	2/136 (1.5%)	2
Other: Overactive Bladder	2/136 (1.5%)	2
Other: Urethral Burning at Foley Catheter Site	2/136 (1.5%)	2
Other: Urine Flow Decreased Force	1/136 (0.7%)	1
Other: Bladder Pressure	1/136 (0.7%)	1
Other: Clot Retention	1/136 (0.7%)	1
Other: Decrease Sense of Emptying Bladder	1/136 (0.7%)	1
Reproductive system and breast disorders
Other: Sexual Dysfunction	1/136 (0.7%)	1
Skin and subcutaneous tissue disorders
Other: Paraphimosis	1/136 (0.7%)	1

Limitations/Caveats

Follow-up of subjects was discontinued in August 2012 prior to most participants completing the assessment planned at 5 years. At the time of the discontinuation, all but five of the participants remaining on study had completed 3 years of follow-up.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.