Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Clinical Trial 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 Design

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT03504111` - PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)	N/A
	Recruiting	`NCT04911920` - Validation of a German Version of the Patient Rated Tennis Elbow Evaluation	N/A

See also

Status

Clinical Trial

Phase

Active, not recruiting

NCT03504111 - PRINT Trial (Platelet Rich Injection vs Needle Tenotomy)

N/A

Recruiting

NCT04911920 - Validation of a German Version of the Patient Rated Tennis Elbow Evaluation

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03487250
Study type	Observational
Source	HydroCision, Inc.
Contact
Status	Completed
Phase
Start date	August 4, 2016
Completion date	April 20, 2019

Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms