NXT Post-Market Clinical Follow-up

Part of paid clinical trials in Hanover, Maryland.

Sponsor
Laborie Medical Technologies Inc.
Study ID
NCT06336304
Status
Recruiting
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Conditions

  • Urinary Bladder, Neurogenic
  • Urinary Bladder, Overactive
  • Urinary Incontinence
  • Urinary Incontinence, Urge
  • Urinary Obstruction

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urodynamic procedure — DIAGNOSTIC_TEST
    Urodynamic procedure

Study Details

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

Key Dates

First listed
Mar 28, 2024
Start date
Jun 18, 2024
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Pediatric
  • Arm: Male Adult Obstructive
  • Arm: Male Adult Incontinence and/or Overactive Bladder
  • Arm: Female Adult Obstructive
  • Arm: Female Adult Incontinence and/or Overactive Bladder
  • Arm: Adults with Neurological Co-morbidities

Primary Outcome Measure

Assess NXT system performance [ Time Frame: 120 Minutes ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Chesapeake Urology HanoverHanoverMaryland21076
Barbara Kyei
Kaiser Robertson, MD (PRINCIPAL_INVESTIGATOR)
Chesapeake Urology Owing MillsOwing MillsMaryland21117
Seema Shahi
Laura Giusto, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Myanah Keys
Christina Ching, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43212
Maxwell Newton
[email protected]
614-366-9561
Iryna Crescenze, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Olusegun Adelaja
[email protected]
434-924-5783
Jacqueline Zillioux, MD (PRINCIPAL_INVESTIGATOR)

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Chesapeake Urology Hanover· Hanover, MDChesapeake Urology Owing Mills· Owing Mills, MDNationwide Children's Hospital· Columbus, OHOhio State University· Columbus, OHUniversity of Virginia· Charlottesville, VA

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