Connective Tissue DefectNCT04880070

Post-Market Clinical Follow Up Study to Collect Additional Data and Imaging

A study testing Shockwave Treatment in people with Connective Tissue Defect, run by Cynosure, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

This is a prospective, open label, multi-center clinical study to collect additional data and imaging for the ViaSure device.The intended use of the ViaSure device used in this study is to assess the usability and tissue response to shock wave treatment. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Connective Tissue Defect
What is being tested?: Shockwave Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2021to 11 May 2021
Phase: Interventional
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A healthy male or female 18 - 65 years of age.
Willing to undergo treatments with the SoftWave device.
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
Understands and accepts the obligation and is logistically able to be present for all visits.
Is willing to comply with all requirements of the study and sign the informed consent document.

Who cannot join

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject has a pacemaker or implantable defibrillator.
The subject has a severe coagulation disorder.
The subject has open epiphyseal plates.
The subject has recently had a steroid injection.
The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months to entering this study.
The subject has any condition or is in a situation which, in the Investigator's opinion, may put the subject at significant risk, may

Trial locations and contacts

1 site in 1 country.

United States1 site

Cynosure, Inc.
Westford, Massachusetts, 01886

Other trials in United States

About this study

Official title: Post Market Clinical Follow Up Study to Collect Additional Data and Imaging

Read the detailed description

Up to 50 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments with the study device. Follow up visits may occur 30 and 90 days post last treatment visit.

Conditions: Connective Tissue Defect
Being tested: Shockwave Treatment

What participants receive

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

Shockwave TreatmentDevice
Self-controlled, single-arm group using the Shockwave device.

Study groups in NCT04880070
Study group	Role	What they receive
Shockwave Device	Experimental	The Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue. Receives: Device: Shockwave Treatment

What is being measured

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

# of Subjects With Altered Gene Expression
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.
Measured: 14 days post treatment

Timeline

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

12 Mar 202111 May 2021

First posted10 May 2021
Study start12 Mar 2021
Primary completion11 May 2021
Study completion11 May 2021

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Connective Tissue DefectStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04880070
Sponsor's protocol ID: SW-MCPM-2021
Status last verified: Jun 2023
First submitted: 5 May 2021
Last updated: 15 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400

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

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All Connective Tissue Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
ClinicalTrials.gov ID: NCT04880070
Acronym / sponsor ID: SW-MCPM-2021
Conditions: Connective Tissue Defect
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2021 (actual)
Primary completion: 11 May 2021 (actual)
Study completion: 11 May 2021 (actual)
First posted: 10 May 2021 (actual)
Results: Posted 15 Jun 2023

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Shockwave Device	Experimental	Device: Shockwave TreatmentThe Shockwave device will be used on multiple areas of the body for the purpose of treating connective tissue.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

A healthy male or female 18 - 65 years of age.
Willing to undergo treatments with the SoftWave device.
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
Understands and accepts the obligation and is logistically able to be present for all visits.
Is willing to comply with all requirements of the study and sign the informed consent document.

Key exclusion criteria (7 listed)

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject has a pacemaker or implantable defibrillator.
The subject has a severe coagulation disorder.
The subject has open epiphyseal plates.
The subject has recently had a steroid injection.

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
Shockwave TreatmentSelf-controlled, single-arm group using the Shockwave device.	Device	Shockwave Device

Primary outcome

# of Subjects With Altered Gene Expression
Time frame: 14 days post treatment
Subjects had their gene expression relative to their own baseline samples analyzed using nSolver 4.0 software, and this was done 14 days post treatment.

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Shockwave Device	5	5

Primary outcome: # of Subjects With Altered Gene Expression

Time frame: 14 days post treatment. Count of participants. Unit: Participants

Measure	Shockwave Device n = 4
Value	4

Population analysed: 1 subject did not have their 14 day sample analyzed.

Adverse events

Time frame: Subjects had their adverse events tracked from the beginning of the study to 14 days post treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Shockwave Device	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

Related trials for Connective Tissue Defect

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
RecruitingObservational study
Study of Chediak-Higashi Syndrome
Chediak-Higashi Syndrome
Not yet recruitingPhase 4
Impact of Dysport on PMFF Donor Scar
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RecruitingObservational study
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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.

Jennifer Civiok study director

Cynosure, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Shockwave Treatment in people with Connective Tissue Defect, run by Cynosure, Inc. at 1 site 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 5 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 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 15 Jun 2023). 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?

# of Subjects With Altered Gene Expression (time frame: 14 days post treatment). 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 NCT04880070, which also lists 1 linked publication.

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 15 Jun 2023.