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Stone and Laser Therapies Post-Market Study (SALT)

Description

The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.

Conditions

Benign Prostate Hypertrophy(BPH)Renal CalculiUreteral Stones, Kidney StonesCalculi, UrinaryUrinary Tract Procedure
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Related Conditions:

Benign Prostate Hypertrophy(BPH)Renal CalculiUreteral Stones, Kidney StonesCalculi, UrinaryUrinary Tract Procedure

Study Overview

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Study Details

Study overview

The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.

Stone and Laser Therapies Post-Market Study

Stone and Laser Therapies Post-Market Study (SALT)

Condition
Benign Prostate Hypertrophy(BPH)
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami Hospital, Miami, Florida, United States, 33442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
  • 2. Subject is willing and able to complete all follow-up visits
  • 1. Subject is ≥ 40 years of age
  • 2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
  • 3. Subject intends to undergo BPH treatment with qualified BSC device(s)
  • 4. Subject is willing and able to complete all follow-up visits
  • 1. Subject requires simultaneous surgical treatment for BPH
  • 2. Unwilling or unable to provide consent
  • 3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
  • 1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
  • 2. Unwilling or unable to provide consent
  • 3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Study Record Dates

2029-02