Heat Wrap Device Safety With Age and Body Fat | NCT01355653

Studies
Heat Wrap Device Safety With Age and Body Fat

NCT01355653

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 2, 2025Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Back Pain

Interventions

thermal therapy
ThermaCare heatwrap

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TC-09-12	Other Identifier	Alias Study Number

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2011Actual

Primary Completion Date

Jul 28, 2011Actual

Completion Date

Jul 28, 2011Actual

First Submitted Date

Apr 28, 2011

First Submission Date that Met QC Criteria

May 17, 2011

First Posted Date

May 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Nov 9, 2012

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Jul 2, 2025Actual

Last Update Submitted Date

Jun 25, 2025

Last Update Posted Date

Jul 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Detailed Description

Safety measurements

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	thermal therapy	Device: thermal therapy
Treatment B	Active Comparator	ThermaCare Lower Back/Hip heatwrap	Device: ThermaCare heatwrap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thermal therapy	Device	heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)		morning after product wear through 15 days after last product application

Secondary Outcomes

Measure	Description	Time Frame
Percentage of subjects with any adverse event		during and after wear for 28 days after last wear

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
Females who are not pregnant or breastfeeding
Subject is medically cleared for study participation

Exclusion Criteria:

No sensitivitiy or allergy to device components in contact with skin
Diabetes
Any active skin disease or tattoos at the test site that would affect participation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University		Loma Linda	California	92350	United States

References Module

Citations

Not provided

ID	Term
D001416	Back Pain
D050177	Overweight

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms