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Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

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ClinicalTrials.gov Identifier: NCT03487250
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
HydroCision, Inc.

Tracking Information
First Submitted Date March 25, 2018
First Posted Date April 3, 2018
Last Update Posted Date April 30, 2019
Actual Study Start Date August 4, 2016
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2018)
Change in elbow pain using Visual Analog Scale (VAS) [ Time Frame: Up to 12 months ]
Change in elbow pain VAS compared to baseline
Original Primary Outcome Measures
 (submitted: March 25, 2018)
Reduction in elbow pain [ Time Frame: Up to 12 months ]
Reduction in elbow pain using the Visual analog scale (VAS) for pain
Change History
Current Secondary Outcome Measures
 (submitted: April 6, 2018)
  • Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE) [ Time Frame: Up to 12 months ]
    Change in PREE compared to baseline
  • Pain medication usage [ Time Frame: Up to 12 months ]
    Reduction in medications for elbow pain
Original Secondary Outcome Measures
 (submitted: March 25, 2018)
  • Elbow Function [ Time Frame: Up to 12 months ]
    Patient-Rated Elbow Evaluation Questionnaire
  • Improvement in Neurological Function [ Time Frame: Up to 12 months ]
    Neurological assessment of the elbow
  • Pain medication usage [ Time Frame: Up to 12 months ]
    Reduction in medications for elbow pain
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Official Title Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
Brief Summary To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Detailed Description This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis
Condition Elbow, Tennis
Intervention Device: TenJet System
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
Study Groups/Cohorts TenJet System
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
Intervention: Device: TenJet System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 28, 2019)
29
Original Estimated Enrollment
 (submitted: March 25, 2018)
50
Actual Study Completion Date April 20, 2019
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient is > 18 years of age
  • Chronic lateral or medial elbow pain > 3 month duration
  • History and clinical examination consistent with lateral or medial epicondylitis
  • Sonographic evidence of medial or lateral elbow tendinosis as evidenced by

    • tendon thickening and hypoechogenicity,
    • with or without hypervascularity on Doppler examination and,
    • with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear.
  • > 3 months of non-operative treatment that included

    • nonsteroidal anti-inflammatory drugs
    • activity modification
    • physical therapy
    • elbow straps
    • With or without previous steroid injections, protein rich plasma injections, or stem cell injections
  • Patient is willing and able to provide informed consent and comply with the study protocol

Exclusion Criteria:

  • Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side)
  • Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure
  • Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
  • Steroid injection within 4 weeks of the study procedure
  • Active local or systemic infection
  • Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament.
  • Patient is known or suspected to be pregnant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03487250
Other Study ID Numbers PUGET-01-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party HydroCision, Inc.
Study Sponsor HydroCision, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Reginald Kapteyn, DO Orthopaedic Associates of Muskegon
PRS Account HydroCision, Inc.
Verification Date April 2019