MedTrace Logo

Treatment of Tendinosis Using the TenJet Hydroresection System

NCT05352139 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-06-21

No results posted yet for this study

Summary

Treatment of recalcitrant tendinopathy remains a clinical challenge for physicians without a minimally invasive treatment option that can consistently provide patients with a long-term relief from chronic pain and ability to return to function.

Surgical debridement of degenerative tendon tissue has long been the standard of care to treat degenerative tendon pathology once all conservative or minimally invasive treatment options have failed.

Ultrasound guided tenotomy is an emerging treatment option with the potential to address the underlying degenerative, diseased tissue, by selectively resecting and removing the tissue in a minimally invasive manner. Additionally, with the availability of in-office diagnostic ultrasound imaging, physicians now have an opportunity to evaluate and classify underlying tendon pathology during a clinical exam. This study is to evaluate outcomes in patients presenting with a clinical history of recalcitrant tendinopathy with confirmed diagnosis of degenerative tendinosis using diagnostic ultrasound imaging or MRI.

Conditions

  • Tendinopathy
  • Tendinosis

Interventions

PROCEDURE

Resection (removal) of the degenerative tissue using the Hydrocision TenJet system

During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.

DEVICE

Hydrocision Tenjet System

The TenJet system will be used during surgery to remove the damaged tissue from the joint

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2024-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05352139 on ClinicalTrials.gov