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Ultrasound Device

Sofwave for Loose Skin

N/A

Waitlist Available

Research Sponsored by Sofwave Medical LTD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months post last treatment

Awards & highlights

Study Summary

This trialtests a new medical treatment on people, with results analyzed by experts to see if it's effective.

Eligible Conditions

Loose Skin

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months post last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months post last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months post last treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body tissue

Trial Design

1Treatment groups

Experimental Treatment

Group I: face and/or neck and/or submental zonesExperimental Treatment1 Intervention

the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sofwave

2020

Completed Phase 3

~240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sofwave Medical LTDLead Sponsor

9 Previous Clinical Trials

552 Total Patients Enrolled

Ruthie Amir, MDStudy DirectorSofwave

4 Previous Clinical Trials

227 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To participate in this research, who meets the qualifications?

"Individuals with cutis laxa who fall between the ages of 35 and 80 may be accepted into this trial. Only 20 people will be enrolled in total."

Answered by AI

Are the patients in this study required to be over 30 years old?

"The age range for patients that this clinical trial is willing to accept starts at 35 years old and goes up to 80 years old."

Answered by AI

Has the FDA given Sofwave their blessing?

"We believe that Sofwave is safe to use (3 out of 3 on our Power scale) because it has gone through Phase 3 clinical trials. This means that there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Are researchers still looking for participants in this trial?

"Yes, this research is presently looking for volunteers. 20 participants are needed at a single site, and according to the clinicaltrials.gov listing, the study was first posted on February 27th 2020 with the most recent update occurring on October 25th 2022."

Answered by AI

How many people are choosing to participate in this research project?

"That is correct, the online information does state that the research team is actively recruiting for this trial. The listing was first posted on February 27th 2020 with the most recent update occurring on October 25th 2022. They are hoping to enrol 20 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow

2020. "SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04969380.