Histological Response of Tissue to Cold
Conditions
Brief summary
This study is designed to characterize the biological response of the epidermis, dermis and subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.
Interventions
DEVICECryo-Touch III
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, 18 to 70 years old * Subject is willing and able to give written informed consent. * Subject is committed to undergo an abdominoplasty procedure independent of this study. * Subject is willing and able to comply with study instructions and commit to all visits for the duration of the study. * Subject is in good general health and free of any disease state or physical condition that might impair evaluation or which in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
Exclusion criteria
* Subject is currently enrolled in an investigational drug or a device study that specifically targets the abdominal area. * Subject currently smokes. * Subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. * Subject has used oral or inhaled steroids in the last 14 days and/or has been a chronic user of inhaled or oral steroids in the past such that the investigator feels subject may have compromised wound healing. * Subject has used topical steroids in the abdominal area within the last 30 days. * Subject is on any systemic immunosuppressive therapy. * Subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of the target treatment sites: liposuction, cryolipolysis, or high-intensity focused ultrasound. * History of abdominal hernia. * Subject has any of the following conditions: * Allergy or intolerance to lidocaine, * Other local skin condition (e.g., skin infection) at target treatment site, * Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation. * Chronic medical condition or use of medication that in the investigator's opinion would affect study participation or wound healing (such as diabetes, hepatitis, HIV, etc.). * Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biological Tissue Response | 7 days | The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs) | 7 days | All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded. |
Countries
United States
Participant flow
Pre-assignment details
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Participants by arm
| Arm | Count |
|---|---|
| Cryo-Touch Treatment Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Biological Tissue Response
The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment.
Time frame: 7 days
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)
All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded.
Time frame: 7 days
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.