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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 1 year
Awards & highlights

Study Summary

This trial is designed to test a new treatment where patients act as their own controls. The study is open-label, meaning that patients and doctors will know which treatment is being given. The study is non-randomized, meaning that patients will not be assigned to treatment groups by chance. The study is prospective, meaning that it will look forward in time to see how patients respond to the new treatment. The study is multi-center, meaning that it will be conducted at more than one hospital or clinic. The study is self-controlled, meaning that each patient will serve as their own control. The study is masked, meaning that the patients will

Eligible Conditions
  • Loose Skin

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of improvement of upper arms lax skin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Upper ArmExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofwave
2020
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Sofwave Medical LTDLead Sponsor
9 Previous Clinical Trials
522 Total Patients Enrolled
Ruthie Amir, MDStudy DirectorCMO
4 Previous Clinical Trials
197 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 there numerous sites in this state where the research is being conducted?

"For those interested in taking part, this trial is being operated from 4 different sites. Two are located in Lincolnshire and New york, with the other two situated in Sacramento and additional locations. To lessen travel requirements for participants, it might be wise to select a centre near you."

Answered by AI

Who is the ideal demographic for participating in this research?

"This clinical trial is searching for 50 individuals experiencing cutis laxa between 35 and 70 years old. They must not be pregnant or lactating, use medically accepted contraception (such as oral contraceptives, contraceptive implants, barrier methods with spermicide), agree to maintain their body weight within 5% of total weight throughout the study, commit to all visits and treatments associated with this trial, abstain from other skin treatments 3 months following Sofwave treatment, have research photographs taken of the affected area(s) if necessary; understand and sign an Informed Consent form."

Answered by AI

Are octogenarians accepted into this medical research?

"This trial is seeking participants aged 35 years old and above, up to the age of 70."

Answered by AI

Is the enrollment period open for this scientific experiment?

"Clinicaltrials.gov reports that this trial, which was first posted on May 1st 2022 and last updated November 20th 2022, is no longer actively recruiting participants. Nevertheless, 13 other medical trials are in search of volunteers right now."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
~17 spots leftby Apr 2025