Elbow, TennisNCT03487250

Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

An observational study of Elbow, Tennis, run by HydroCision, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Elbow, Tennis
What is being tested?: TenJet System
Type of treatment: Medical device
How many people: 29 participants
Where: 3 sitesUnited States
Study dates: 4 Aug 2016to 20 Apr 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis

Who may be able to join

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,

Show all 14Show fewer

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Penn Highlands
DuBois, Pennsylvania, 15801
Noble Pain Management & Sports Medicine
Fort Worth, Texas, 76110
Orthopaedic Associates of Muskegon
Muskegon, Michigan, 49444

Other trials in United States

About this study

Official title: Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System

To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

Read the 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.

Conditions: Elbow, Tennis
Being tested: TenJet System
Medical subject headings: Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TenJet SystemDevice
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Study groups in NCT03487250
Study group	Role	What they receive
TenJet System		Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System Receives: Device: TenJet System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Elbow Pain Using Visual Analog Scale (VAS)
Change in elbow pain (VAS) compared with baseline. VAS range 0 (no pain) to 10 (intolerable pain); higher scores indicate worse pain. Mean change is calculated as baseline minus follow-up, so positive values indicate improvement. Time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months.
Measured: Up to 12 months

Secondary outcomes (1)

Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE)
Change in total PREE score compared with baseline on a 0-100 scale (lower scores indicate less pain/higher function). Mean change is calculated as baseline minus follow-up (positive = improvement) and reported at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 201620 Apr 2019

First posted3 Apr 2018
Study start4 Aug 2016
Primary completion20 Apr 2019
Study completion20 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Elbow, TennisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03487250
Sponsor's protocol ID: PUGET-01-016
Status last verified: Apr 2026
First submitted: 25 Mar 2018
Last updated: 7 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

All Elbow, Tennis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
ClinicalTrials.gov ID: NCT03487250
Acronym / sponsor ID: PUGET-01-016
Conditions: Elbow, Tennis
Study type: Observational
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: HydroCision, Inc.Industry (pharma, biotech, devices)
Study start: 4 Aug 2016 (actual)
Primary completion: 20 Apr 2019 (actual)
Study completion: 20 Apr 2019 (actual)
First posted: 3 Apr 2018 (actual)
Results: Posted 7 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
TenJet System	–	Device: TenJet SystemPercutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis

Key inclusion criteria (14 listed)

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
> 3 months of non-operative treatment that included

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TenJet SystemPercutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System	Device	TenJet System

Primary outcome

Change in Elbow Pain Using Visual Analog Scale (VAS)
Time frame: Up to 12 months
Change in elbow pain (VAS) compared with baseline. VAS range 0 (no pain) to 10 (intolerable pain); higher scores indicate worse pain. Mean change is calculated as baseline minus follow-up, so positive values indicate improvement. Time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months.

1 secondary outcome

Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE)
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 7 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TenJet System	29	25

Primary outcome: Change in Elbow Pain Using Visual Analog Scale (VAS)

Time frame: Up to 12 months. Mean (Standard Deviation). Unit: VAS Score

Measure	Baseline n = 29	2 Weeks n = 29	6 Weeks n = 28	3 Months n = 26	6 Months n = 26	12 Months n = 25
VAS Score	5.1 (2.5)	3.0 (1.7)	1.9 (1.7)	1.1 (1.2)	0.7 (1.0)	0.5 (0.9)
Mean improvement over baseline	–	2.2 (2.3)	3.0 (2.4)	3.9 (2.7)	4.3 (2.8)	4.4 (3.0)

Population analysed: Baseline includes 29 participants contributing 32 elbows; follow-up is analyzed per elbow. At the 12-month timepoint, 27 elbows (25 participants) completed follow-up, as reported in the Participant Flow. However, VAS outcome data were available for 26 elbows. One elbow did not have a recorded VAS score at 12 months due to a missing patient-reported outcome. Therefore, analyses of VAS at 12 months are based on the 26 elbows with available data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TenJet System	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Elbow, Tennis

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Reginald Kapteyn, DO principal investigator

Orthopaedic Associates of Muskegon

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Elbow, Tennis, run by HydroCision, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Elbow Pain Using Visual Analog Scale (VAS) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03487250.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.