Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects

• Sponsor: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01681745
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Histological Response of Tissue to Cold	Device: Cryo-Touch III	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
• Actual Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Cryo-Touch III; Other Names: PCP 1.0

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	77 Plastic Surgery	San Francisco	California	United States	94102

Sponsors and Collaborators

• Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
• ClinicalTrials.gov Identifier: NCT01681745
• Other Study ID Numbers: MYO-0535
• First Posted: Sep 10, 2012
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Cryo-Touch Treatment
Arm/Group Description	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cryo-Touch Treatment
Arm/Group Description	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
Overall Participants	0
Age (years) []
Sex: Female, Male () []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Biological Tissue Response
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cryo-Touch Treatment
Arm/Group Description	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
Measure Participants	0

2. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cryo-Touch Treatment
Arm/Group Description	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
Measure Participants	0

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Cryo-Touch Treatment
Arm/Group Description	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.
All Cause Mortality
	Cryo-Touch Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cryo-Touch Treatment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cryo-Touch Treatment
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.