Evaluation of Efficacy and Safety of the triLift™ System (LUM-triLift)

March 6, 2023 updated by: Lumenis Be Ltd.
Single center, single-arm, prospective, open Label with Before & After Study Design.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10028
        • Recruiting
        • NY Laser Skin Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is willing and able to read, understand, and sign the informed consent.
  • Healthy male or female aged 35 - 55 years.
  • Fitzpatrick skin type 1-6.
  • Subject is capable of reading, understanding, and following instructions of the procedure to be applied.
  • Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.

Exclusion Criteria:

  • Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
  • Concurrent participation in any other study.
  • Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
  • Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
  • Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
  • Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
  • Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study.
  • Subject has used topical retinoids in the past 1 month.
  • History of systemic cancer; premalignant skin lesion or skin concern treatment area.
  • Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
  • Poorly controlled endocrine disorders such as diabetes.
  • Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
  • History of collagen disorders, keloid formation or abnormal wound healing.
  • Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing.
  • Subject has used oral steroids in the past 6 months.
  • Subject has used topical steroids in the past 3 months.
  • History of bleeding coagulopathies or use of anticoagulants.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment.
  • Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.)
  • Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements.
  • Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Trilift system treatment arm
Single arm with Before & After photos, triLift treatment protocol study design.
Device: triLift system
To evaluate the efficacy of the triLift™ treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Global Aesthetic Improvement scale (GAI)
Time Frame: 4 months
The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D images
Time Frame: 4 months
Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol
4 months
Comfort assessment
Time Frame: 3 months
Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), where 0 is "no pain" and 10 is "worst pain possible
3 months
Subject level of Satisfaction
Time Frame: 4 months
Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumenis Be Ltd.

Investigators

  • Principal Investigator: Arielle Kauvar, MD, New York Laser & Skin Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2023

Primary Completion (Anticipated)

August 15, 2023

Study Completion (Anticipated)

August 15, 2023

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUM-ABU-triLift-22-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wrinkle

Clinical Trials on triLift system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe