Status:
COMPLETED
Effectiveness Study of MIST Therapy After Cosmetic Surgery Procedures of the Face and Body
Lead Sponsor:
Celleration, Inc.
Conditions:
Cosmetic Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
A clinical trial to evaluate the effect of MIST Therapy on outcomes after cosmetic procedures(including facelifts, blepharoplasties, breast augmentations and reductions, mastopexies, and abdominoplast...
Detailed Description
A post-market, single-center, prospective, randomized, single-blinded study. Each subject serves as her/his own control. The procedures chosen are bilateral, and each subject will have one side of th...
Eligibility Criteria
Inclusion
- Subject must be between 18-75 years of age
- Subject must be compliant with the study visits
- Subject must be in good health
- Subject must be able to provide written informed consent
- Subject must be undergoing one or more of the following bilateral procedures:
- Rhytidectomies
- Blepharoplasty
- Breast augmentation
- Mastopexy
- Breast reduction
- Abdominoplasty
Exclusion
- Subject has any medical condition that would result in poor wound healing
- Subject has any medical condition that would result in poor scarring
- Subject is taking medications that may affect healing or scarring, including Arnica
- Subject has diabetes
- Area to be treated has been irradiated
- Subject is undergoing a secondary procedure that may be associated with prior scar tissue in the area undergoing surgery
- Subject has any medical condition that in the opinion of the Investigator would make the subject an inappropriate candidate for this study, including a higher than usual concern for surgical complications
- Subject has electronic implants or prosthesis
- Subject has cardiac pacemaker
- Pregnant woman
- Skin cancer
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
3440 Patients enrolled
Trial Details
Trial ID
NCT01206855
Start Date
October 1 2010
End Date
December 1 2013
Last Update
October 8 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611