China Greenlight Registry Study (Post-market)

NCT03736512 | Completed

• 1 other identifier: U0597
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• The GreenLight XPS system provides durable relief of BPH symptoms in subjects.

  Changes of IPSS Scores in subjects treated with the GreenLight XPS Laser System at 6 months

  6-month follow up

Interventions

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

observational registry

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Men diagnosed with benign prostatic hyperplasia (BPH) for whom GreenLight Laser therapy is recommended by their physician and eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men diagnosed with benign prostatic hyperplasia (BPH) for whom GreenLight Laser therapy is recommended by their physician and eligible for inclusion.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jian Huang, Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: November 9, 2018
• Study Start: February 27, 2019
• Primary Completion: March 30, 2021
• Study Completion: November 29, 2021
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

CN (1)