Use of V-Loc Suture for Mid-face Lifting in Short-flap Rhytidectomy

NCT ID: NCT02023307

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-08-31

Brief Summary

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This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when using a short flap, short incision technique in during a traditional face-lift. The objective of this study is to assess the suture's potential in elevating the mid-face when a traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate the mid-face more effectively when using a short flap, short incision technique on a traditional facelift.

Detailed Description

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A total of 25 patients who are already receiving a traditional Lifestyle Lift will be asked to participate. Once the consent form has been signed by the patient, the facelift will be performed as scheduled and the Vloc suture will be added to the mid-face area. Each patient will be added to a database and their progress will be tracked with photos taken before, at 6 weeks, and at 6 months following the procedure. All data stored will be locked into a hard drive that can only be accessed by the research staff and the doctor. The text data will be used by research staff for reports and articles.

\* you must already have purchased and scheduled a facelift procedure with Lifestyle Lift to participate in this trial. The addition of only the V-loc suture is at no cost.

Conditions

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Use of the Vloc Suture Elevation of the Mid-face

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rhytidectomy with Covidien

25 patients receiving a mid-face lift in short-flap rhytidectomy

Group Type EXPERIMENTAL

V-Loc Suture

Intervention Type DEVICE

Interventions

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V-Loc Suture

Intervention Type DEVICE

Other Intervention Names

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Covidien

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled to receive a Lifestyle Lift will be asked to participate. The first 25 patients who have consented will be included into the study.

Exclusion Criteria

* Any patient who is not able to receive a facelift for whatever reason, or who do not want a facelift will not be apart of this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lifestyle Lift

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lifestyle Lift

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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20131586

Identifier Type: -

Identifier Source: org_study_id

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