Treatment of Adipose Tissue and Skin Laxity at the Buttoc... | NCT07010796

Studies
Treatment of Adipose Tissue and Skin Laxity at the Buttocks by PDLLA, US and RF

NCT07010796

Sponsor

Pablo Naranjo García, MD

Status

Completed

Last Update Posted

Jun 11, 2025Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Local Fat Deposits

Interventions

Alma Prime X

Countries

Spain

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

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

Jan 15, 2025Actual

Primary Completion Date

May 15, 2025Actual

Completion Date

May 15, 2025Actual

First Submitted Date

May 30, 2025

First Submission Date that Met QC Criteria

May 30, 2025

First Posted Date

Jun 8, 2025Actual

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

Jun 8, 2025

Last Update Posted Date

Jun 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pablo Naranjo García, MD, Principle Investigator Pablo Naranjo Garcia, MD, Elite Laser ClinicSponsor-Investigator

Lead Sponsor

Pablo Naranjo García, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Local body fat and lax skin is treated with a combined approach of PDLLA injections and topical ultrasound and radiofrequency.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alma Prime X	Device	Alma Prime x is a platform that provides applicators for radiofrequency and ultrasound.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of fat deposits		From enrollment to the end of treatment at 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults over 18 years
patients eligible to be treated with radiofrequency and ultrasound
all genders

Exclusion Criteria:

patients displaying contraindications for treatment with radiofrequency and ultrasound
pregnancy
immune diseases
active virus infections

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants were selected due to their desire to reduce fat deposits at the buttock area as well as tightening lax skin.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Elite Laser Clinic Organization		Madrid		28005	Spain