Effect of the XP1100RF Therapy on Thighs Circumference Re... | NCT02527369

Studies
Effect of the XP1100RF Therapy on Thighs Circumference Reduction

NCT02527369

Sponsor

BTL Industries Ltd.

Status

Completed

Last Update Posted

Jul 13, 2020Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Thighs Circumferential Reduction
Subcutaneous Fat Cell Disruption

Interventions

XP1100RF

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

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

Jul 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jul 30, 2015

First Submission Date that Met QC Criteria

Aug 17, 2015

First Posted Date

Aug 19, 2015Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2020

Last Update Posted Date

Jul 13, 2020Actual

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 was designed to demonstrate safety and efficacy of the XP1100RF for non-invasive temporary reduction of thighs circumference by disruption of adipocyte cells.

Detailed Description

This study is a prospective, single-arm, open label study of thighs circumference reduction following 4 treatment sessions delivered once a week over a 4-week period. The objective of the study is to demonstrate the effectiveness of the treatment after 30-day in achieving thighs circumference reduction of ≥1 cm relative to the base line assessment.

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XP1100RF group	Experimental	Subjects in the XP1100RF group will be treated with the XP1100RF device.	Device: XP1100RF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XP1100RF	Device	Treatment of adipose tissue within the fat layer with XP1100RF device.	XP1100RF group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thighs Circumference Reduction from Baseline at 30 days Follow Up	The primary efficacy outcome measure is set to be a minimum of 80% of subjects at 30-day follow up evaluation to show thighs circumference reduction of ≥1 cm below the gluteal fold relative to the base line assessment.	30 days Follow Up

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Absence of adverse events (AE) associated with the treatment procedure. Safety evaluations of skin reaction in the treatment area would be conducted at every treatment and follow up visits.	30 days Follow Up
Adverse Events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body Mass Index (BMI) of 20 to 35 kg/m2.
Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
Diabetics dependent on insulin or oral hypoglycemic medications
Known cardiovascular disease such as arrhythmias, congestive heart failure
Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
Prior surgical interventions for body sculpting of thighs such as liposuction
Medical, physical or other contraindications for body sculpting/ weight loss
Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
Any medical condition known to affect weight levels and/or to cause bloating or swelling
Active infection, wound or other external trauma to the area to be treated
Pregnant, breast feeding, or planning pregnant before the end of the study
Serious mental health illness
Active or recurrent cancer or current chemotherapy and/or radiation treatment
Negative affection to heat

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 12, 2020
Reset	Aug 25, 2020
Release	Sep 10, 2020
Reset	Sep 30, 2020

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 12, 2020			Aug 25, 2020
Sep 10, 2020