Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04587804
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2020-10-08
Brief Title:
Abdomen - Fat Reduction and Muscle Toning
Sponsor:
BTL Industries Ltd
Organization:
BTL Industries Ltd
Study Overview
Official Title:
Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation rPMS and Radiofrequency
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat The study is a prospective multi-center open-label single-arm study The subjects will be enrolled and assigned into a single study group Subjects will be required to complete three 3 treatment visits and two to three follow-up visits All of the study subjects will receive the treatment with the subject device
Detailed Description:
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat The study is a prospective multi-center open-label single-arm study The subjects will be enrolled and assigned into a single study group Subjects will be required to complete three 3 treatment visits and two to three follow-up visits All of the study subjects will receive the treatment with the subject device
At the baseline visit MRI will be performed subjects weight and waist circumference will be recorded Photos of the treated area will be taken
The treatment administration phase will consist of three 3 treatments delivered once a week The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device
At the last therapy visit the subjects weight and waist circumference will be recorded and photos of the treated area will be taken In addition subjects will receive Subject Satisfaction Questionnaire to fill in
Safety measures will include documentation of adverse events AE including subjects experience of pain or discomfort after each procedure Following each treatment administration and at all of the follow-up visits subjects will be checked for immediate post-procedure adverse event assessment
During the post-procedure visits at 1-month and 3-month follow-up visits the subjects will undergo MRI scanning Also subjects satisfaction will be noted and weight with waist circumference will be recorded Photographs of the treated area will be taken There will be an option of a 6-months follow-up visit according to subjects availability
At the baseline visit MRI will be performed subjects weight and waist circumference will be recorded Photos of the treated area will be taken
The treatment administration phase will consist of three 3 treatments delivered once a week The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device
At the last therapy visit the subjects weight and waist circumference will be recorded and photos of the treated area will be taken In addition subjects will receive Subject Satisfaction Questionnaire to fill in
Safety measures will include documentation of adverse events AE including subjects experience of pain or discomfort after each procedure Following each treatment administration and at all of the follow-up visits subjects will be checked for immediate post-procedure adverse event assessment
During the post-procedure visits at 1-month and 3-month follow-up visits the subjects will undergo MRI scanning Also subjects satisfaction will be noted and weight with waist circumference will be recorded Photographs of the treated area will be taken There will be an option of a 6-months follow-up visit according to subjects availability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None