Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT01702259
Eligibility Criteria:
Inclusion Criteria:
* Areas for which cellulite appearance reduction is being sought are the bilateral thighs and buttocks
* Clinical cellulite gradation of Stage II or III on the Nurnberger-Muller scale for each treatment area
* PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System
* Willing and able to abstain from partaking in any treatment other than the study procedure to promote cellulite appearance reduction/body contouring/weight loss during the study
* Willing and able to maintain regular diet and exercise regimen without effecting significant change in either direction during the study
* Willing and able to maintain regular medication schedule, as is medically feasible, during the study
Exclusion Criteria:
* Clinical cellulite gradation of Stage 0 or I on the Nurnberger Muller Scale (NMS) for either one or both thighs/buttocks
* P3 or P4 or P5 or P6 on the ASA Physical Status Classification System
* Weight fluctuation greater than 10 pounds in the prior month
* Previous attempt(s) to reduce cellulite in the study treatment areas over the past 6 months
* Prior surgical intervention to the treatment areas, for any reason
* Medical, physical or other contraindications for cellulite reduction/body contouring/weight loss
* Current use of medication(s) known to affect weight levels and/or cause bloating or swelling and for which abstinence during the study is not safe or medically prudent
* Any medical condition known to affect weight levels, cause bloating or swelling
* Diagnosis of, and/or taking medication for, irritable bowel syndrome
* Active infection, wound or other external trauma to the study treatment areas
* Dermatitis or significant scarring in the study treatment areas
* Medical, physical, or other contraindications for, or known sensitivity to, light therapy
* Diabetes dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease
* Cardiac surgeries
* History of deep venous thrombosis, arterial disease of the legs
* Pregnant, breast feeding, or planning pregnancy prior to study end
* Serious mental health illness or psychiatric hospitalization in past 2 years
* Developmental disability or cognitive impairment that would impact study participation
* Involved in litigation/receiving disability benefits related to the parameters of the study
* Participation in research in the past 30 days
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01702259
Study Brief:
Protocol Section:
NCT01702259