Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404372
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone PDO Suture
Sponsor:
Sutura Medical Technology LLC
Organization:
Sutura Medical Technology LLC
Study Overview
Official Title:
A Pivotal Blinded Multi-Center Study to Show the Safety and Effectiveness of the Demetech Barbed PDO Suture
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical trial sponsored by Sutura Medical Technology Inc is a pivotal blinded multi-center study assessing the safety and effectiveness of the Demetech Barbed PDO Suture an absorbable Polydioxanone suture for the temporary treatment of midface wrinkles The trial will enroll 57 subjects across up to four sites following them over a 12-month period to evaluate improvements in wrinkles based on the Lemperle Classification Facial Wrinkle Scale Primary endpoints include assessing the rate of adverse events and a significant reduction in wrinkle severity at 6 months with secondary endpoints focusing on longer-term results and patient satisfaction
Detailed Description:
The study will be a pivotal blinded multi-center study to evaluate the safety and effectiveness of Demetech Barbed PDO Suture for the treatment of mid face wrinkles Subjects who meet InclusionExclusion criteria will receive treatment with Demetech Barbed PDO Sutures Fifty-seven subjects will be treated In addition up to 2 run-in subjects may be treated with Demetech Barbed PDO Sutures by the investigator to allow the investigator to become familiar with Demetech Barbed PDO Suture characteristics This run-in cohort will be required to meet all study inclusionexclusion criteria and will be followed in the same manner as the non-run-in cohort
Primary effectiveness will be assessed at 6 months All subjects will be followed for a minimum of 12 months after treatment Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment
The primary effectiveness endpoint will be determined by the proportion of subjects with 1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators The Lemperle Scale will be used for photographic assessment by the blinded panel Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator as well as Investigator- and Subject-rated GAIS and FACE-Q
Safety will be assessed at each follow-up visit Subjects will be seen for follow up visits at 2 weeks 6 weeks 3 months 6 months 9 months and 12 months from treatment
Primary effectiveness will be assessed at 6 months All subjects will be followed for a minimum of 12 months after treatment Subjects will be followed up for safety via telephone or email at 72 hours after receiving treatment
The primary effectiveness endpoint will be determined by the proportion of subjects with 1 point improvement on the Lemperle Classification of Facial Wrinkles Scale at 6 months compared to baseline as rated by a panel of three blinded evaluators The Lemperle Scale will be used for photographic assessment by the blinded panel Assessment of the secondary effectiveness endpoints will include the use of the Lemperle Scale by photograph by the blinded panel and live by the Investigator as well as Investigator- and Subject-rated GAIS and FACE-Q
Safety will be assessed at each follow-up visit Subjects will be seen for follow up visits at 2 weeks 6 weeks 3 months 6 months 9 months and 12 months from treatment
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?:
None
Is an FDA AA801 Violation?:
None