China Greenlight Registry Study (Post-market)

NCT ID: NCT03736512

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2021-11-29

Brief Summary

The duration of the study is expected to take approximately 3 years, which includes a recruitment period of approximately 12-months and 2 years (24-months) to complete procedure and follow-up visits.

Detailed Description

The study follow-up duration from the primary study procedure is 5 years.

• Baseline
• Study Procedure
• 4-week
• 6-month
• 12-month
• 24-month (End of Study) The study will be considered complete after all subjects have completed the 24-month follow-up visit.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber

observational registry

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject has provided informed consent and agrees to attend all study visits
• Subject has a diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
• Subject is able to complete self-administered questionnaires
• Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for the PVP procedure
• Subject is ≥ 40 years of age
• Subject has an IPSS score greater than or equal to 12 measured at the baseline visit

Exclusion Criteria

• Subject has medical record documentation of a prostate volume of greater than or equal to 30 grams by transrectal ultrasound (TRUS))

• Subject has a life expectancy of less than 2 years
• Subject is classified as American Society of Anesthesiologists (ASA) V
• Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
• Subject has an active infection that would preclude operation within 14 days of the study procedure (e.g., urinary tract infection or prostatitis)
• Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (e.g., non-bacterial chronic prostatitis)
• Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injuries)
• Subject has a diagnosis of polyneuropathy (e.g., diabetic)
• Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
• Subject has a diagnosis of prostate cancer or suspected prostate cancer based on PSA results and meeting the following:

PSA level of 4 - 10 with an abnormal DRE (if biopsy collected must be positive); PSA level greater than 10 with a positive biopsy

• Subject has a history of CIS, TaGIII or any T1 stage bladder cancer
• Subject has damage to external urinary sphincter
• Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent
• Subject is immunocompromised (e.g., organ transplant, leukemia)
• Subject currently or has a history of upper urinary tract stones
• Subject currently diagnosed with OAB and treated with medication If the subject does not carry a diagnosis but is suspected to have OAB, the investigator must use his/her discretion

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen Memorial Hosptital, Sun Yat-sen University

Locations

Sun Yat-sen Memorial Hosptital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

U0597

Identifier Type: -

Identifier Source: org_study_id