| CTRI Number |
CTRI/2025/08/093106 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A three-month clinical study to evaluate the effectiveness of the device in body shaping |
|
Scientific Title of Study
|
A Clinical Evaluation of the Efficacy of the Density Device for Non-Invasive Body Contouring over a 3-Month Period |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/JSBC/2025-01 Version 1.0, dated 18 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd 327/15,1st Main Road, Cambridge layout, Ulsoor
Department of Skin Sciences
324 Second Floor
1st Main Road Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and operations |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
327/15 1st Main Road Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09080826918 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
manager- Techno commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15,1st Main Road, Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Jeisys Medical Inc.
Address #307, 96, Gamasan-ro, Geumcheon-gu, Seoul, South Korea (ZIP 08501)
|
|
|
Primary Sponsor
|
| Name |
Jeisys Medical Inc. |
| Address |
#307, 96, Gamasan-ro, Geumcheon-gu, Seoul, South Korea (ZIP 08501)
Email: narendrakumar@jeisys.com
|
| Type of Sponsor |
Other [medical device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
female participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DST101 |
It is a general-purpose electrosurgical device and treats using RF frequency. When high RF is irradiated on the skin, coagulation occurs with heat action of skin tissue, resulting in tissue treatment. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Female Trial participants aged between 25-60 years.
2. Skin Laxity: Visible mild to moderate skin laxity or sagging.
3. Participants who agree to maintain their existing lifestyle- dietary habits and skincare routine throughout the study duration.
4. Trial participants able to read, speak, write and understand the informed consent form and provide consent for study procedures.
5. Trial participants willing to comply with the protocol.
6. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
|
|
| ExclusionCriteria |
| Details |
1. Trial Participants with known active skin infections.
2. Trial participants with severe skin redundancy.
3. Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
4. Trial participants having any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious/chronic medical illness or have undergone major surgery in the last year.
5. Trial participants who are pregnant or nursing (self-declared).
6. A known history or present condition of allergic response to any skincare or cosmetic treatments/procedures.
7. Trial participant who is an employee of the sponsor or the CRO.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in body contour of the treatment site in comparison to baseline based on dermatological and instrumental evaluations |
Day 1 or 2, Day 30, Day 90 and Day 210 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Perceived changes of the treatment site in comparison to baseline based on patient reported outcome. |
Day 1 or 2, Day 30, Day 90 & Day 210 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
29/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/01/2026 |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This clinical study aims to assess the performance of the Jeisys Density device for body contouring in female participants aged 25 to 60 years. A total of four visits will be scheduled: Visit 1 for screening, Visit 2 for baseline, procedure, and immediate post-procedure assessment, Visit 3 on Day 30, Visit 4 on Day 90 and Visit 5 on Day 210 for follow-up evaluations. Changes in body measurements and contour at the treatment site will be assessed using dermatological, instrumental, and patient-reported evaluations. Safety will be monitored throughout the study to identify any adverse effects. |