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Procedure

lax tissue for Loose Skin

N/A

Recruiting

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 months post treatment follow-up visit

Awards & highlights

Study Summary

This trial is a study where participants know what treatment they are receiving, and it is not randomly assigned. It will be conducted at multiple centers and will evaluate the treatment without the participants knowing the results until

Who is the study for?

This trial is for healthy adults aged 35-80 who want to improve facial wrinkles and lift lax skin, without undergoing other cosmetic treatments for 3 months post-trial. Participants must be non-smokers with stable weight, not pregnant or breastfeeding, and using reliable birth control if applicable.Check my eligibility

What is being tested?

The study tests the Sofwave treatment's effectiveness on lifting loose facial skin and reducing wrinkles. It's an open-label, single-arm study where all participants receive the same treatment with outcomes evaluated by masked assessors.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones from similar procedures may include temporary redness, swelling at the treatment site, discomfort during application, and rare risks of burns or scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post treatment follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post treatment follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post treatment follow-up visit for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Measure

Trial Design

1Treatment groups

Experimental Treatment

Group I: lax tissueExperimental Treatment1 Intervention

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

472 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals aged 50 and above eligible to participate in this research project?

"The trial is seeking individuals above 35 years of age but under the age of 80 for enrollment."

Answered by AI

How many participants are currently undergoing treatment within this clinical trial?

"Indeed, information from clinicaltrials.gov indicates that this research endeavor is actively seeking participants. The trial was first listed on October 11th, 2023 and most recently revised on March 20th, 2024. Approximately a total of 100 individuals are sought across two distinct sites for enrollment in the study."

Answered by AI

Is the recruitment phase currently open for this clinical trial?

"Affirmative. Information on clinicaltrials.gov confirms the ongoing recruitment for this research endeavor. The trial was initially listed on October 11, 2023, and last modified on March 20, 2024. It aims to enroll a total of 100 volunteers across two designated sites."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"Candidates eligible for inclusion in this study must exhibit lax skin and fall within the age bracket of 35 to 80 years. The trial aims to enroll a total of 100 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators

2023. "Treatment to Lift Facial Lax Skin and Improve Facial Wrinkles Using Precise and Lift Applicators". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06333067.

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