← Back to Search

Procedure

Patients Receiving Lipoaspirate with Viality for Fat Tissue

N/A

Recruiting

Research Sponsored by Sientra, Inc.

Eligibility Criteria Checklist

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

Must have

Patients undergoing an aesthetic fat grafting procedure to the face

Anticipated fat injection volume 40-55 cc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial seeks to understand the effects of facial fat grafting using an FDA-cleared device.

Who is the study for?

This trial is for women aged 18-65 planning to undergo aesthetic fat grafting to the face. They must be non-smokers, able to maintain their weight, provide consent, and follow study procedures. Excluded are those with skin rashes, bleeding disorders, past facial trauma or surgery, infections, compromised immune systems, untreated substance abuse issues or who are pregnant/breastfeeding.Check my eligibility

What is being tested?

The trial studies the effects of using the Viality system in facial fat grafting. This FDA-cleared device will be used for tissue replacement and regeneration in patients' midfacial areas to assess both short-term and long-term outcomes.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include reactions at injection sites such as swelling or bruising; infection risk; potential discomfort from the procedure; and possible dissatisfaction with cosmetic results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a cosmetic fat transfer to my face.

Select...

I am expected to receive a fat injection of 40-55 cc.

Select...

I have suitable body areas for fat removal for grafting.

Select...

I am a woman aged between 18 and 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Facial Fat Volume Retention

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients Receiving Lipoaspirate with VialityExperimental Treatment1 Intervention

Patient will be undergoing fat transfers to the face with lipoaspirate processed using the Viality wash system.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sientra, Inc.Lead Sponsor

6 Previous Clinical Trials

7,625 Total Patients Enrolled

Faces+OTHER

Sara SaulStudy DirectorCoordinator

Frequently Asked Questions

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

What are the requirements for joining this research endeavor?

"In order to gain entry into this clinical trial, applicants must possess adipose tissue and be between the ages of 18-65. The full cohort is expected to consist of 20 individuals."

Answered by AI

Does this research endeavor accept individuals over the age of sixty as participants?

"The requirements for entry into this clinical trial stipulate that participants must be aged between 18 and 65."

Answered by AI

Are there any vacant slots accessible to participants in this clinical experiment?

"Yes, according to the clinicaltrials.gov database, this medical trial is actively enlisting patients that meet its criteria. This research was initially publicised on November 13th 2023 and then revised in December 5th of the same year. A total of 20 participants are being sought at a single site for enrollment."

Answered by AI

How many patients are participating in this trial at maximum capacity?

"Affirmative. The records posted on clinicaltrials.gov reveal that this medical trial, which was originally uploaded on November 13th 2023, is actively recruiting participants. At present, one site needs to enroll twenty patients as part of the study's protocol."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Fat Grafting to the Face With Use of the Viality™ System

Steven Cohen 2023. "Autologous Fat Grafting to the Face With Use of the Viality™ System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06169670.