Hello! At JNPMEDI, we’ve prepared an update on the medical device clinical trial plans approved in November.
Shall we take a closer look? ๐
The clinical trial plans approved in November highlight the use of innovative technologies, including various therapeutic and diagnostic support software as well as medical laser devices, in the treatment and diagnosis of diverse conditions.
The ‘SAT-014’ software and ‘Avecmom’ digital therapeutic device, aimed at improving mental health, focus on alleviating both mental and physical symptoms. Meanwhile, the ‘AiTiALVDD’ ECG analysis software and ‘JLK-CTL,’ which utilizes brain CT imaging, are under development as AI-powered diagnostic support technologies.
Additionally, advanced medical devices such as low-level laser systems and position-adjustable catheters are undergoing evaluations to demonstrate their safety and efficacy compared to conventional treatments. These studies are expected to significantly contribute to the advancement of medical technology and the realization of personalized patient care.
The clinical trial for tissue-repair materials targeting bilateral crow's feet (wrinkles around the eyes) approved on November 1 did not employ a matched-pair design. However, have you ever heard of the term "matched-pair design" in clinical trials involving tissue-repair materials or bio-materials?
The matched-pair design is a research method used in clinical trials for tissue-repair materials and bio-materials, leveraging symmetrical body areas to directly compare the effects of the investigational device and the control device. For instance, data is collected by applying the investigational device and the control device to the left and right sides of symmetrical structures, such as nasolabial folds, midface, or crow's feet, within the same subject.
Unlike parallel designs, where each subject is assigned to only one device, this method offers the advantage of increasing data consistency through within-subject comparisons, while reducing the number of subjects required.
This design minimizes inter-subject variability, allowing for more precise comparisons, thereby enhancing the reliability of clinical trials. However, to implement this design, the two areas must be visually symmetrical within a predefined scoring range, although they do not need to have completely identical wrinkle scores. Subjects may be excluded if symmetry requirements are not met.
With its numerous advantages, the matched-pair design is widely used in trials for tissue-repair materials or bio materials. Since 2008, the Ministry of Food and Drug Safety (MFDS) has approved clinical trial plans using this design for indications such as nasolabial folds, crow's feet, and midface volume.
We’ll be back soon next month with more updates on medical device clinical trial approvals and other valuable news ๐
โถ References
Shin, Hyewon, Juneyoung Lee, and Hyonggin An. "Simulation Study for Comparison between ITT and PP in Matched Pair Noninferiority Clinical Trials." Journal of Health Informatics and Statistics Korea Vol 36 No.2 (2011)
Hello! At JNPMEDI, we’ve prepared an update on the medical device clinical trial plans approved in November.
Shall we take a closer look? ๐
The clinical trial plans approved in November highlight the use of innovative technologies, including various therapeutic and diagnostic support software as well as medical laser devices, in the treatment and diagnosis of diverse conditions.
The ‘SAT-014’ software and ‘Avecmom’ digital therapeutic device, aimed at improving mental health, focus on alleviating both mental and physical symptoms. Meanwhile, the ‘AiTiALVDD’ ECG analysis software and ‘JLK-CTL,’ which utilizes brain CT imaging, are under development as AI-powered diagnostic support technologies.
Additionally, advanced medical devices such as low-level laser systems and position-adjustable catheters are undergoing evaluations to demonstrate their safety and efficacy compared to conventional treatments. These studies are expected to significantly contribute to the advancement of medical technology and the realization of personalized patient care.
The clinical trial for tissue-repair materials targeting bilateral crow's feet (wrinkles around the eyes) approved on November 1 did not employ a matched-pair design. However, have you ever heard of the term "matched-pair design" in clinical trials involving tissue-repair materials or bio-materials?
The matched-pair design is a research method used in clinical trials for tissue-repair materials and bio-materials, leveraging symmetrical body areas to directly compare the effects of the investigational device and the control device. For instance, data is collected by applying the investigational device and the control device to the left and right sides of symmetrical structures, such as nasolabial folds, midface, or crow's feet, within the same subject.
Unlike parallel designs, where each subject is assigned to only one device, this method offers the advantage of increasing data consistency through within-subject comparisons, while reducing the number of subjects required.
This design minimizes inter-subject variability, allowing for more precise comparisons, thereby enhancing the reliability of clinical trials. However, to implement this design, the two areas must be visually symmetrical within a predefined scoring range, although they do not need to have completely identical wrinkle scores. Subjects may be excluded if symmetry requirements are not met.
With its numerous advantages, the matched-pair design is widely used in trials for tissue-repair materials or bio materials. Since 2008, the Ministry of Food and Drug Safety (MFDS) has approved clinical trial plans using this design for indications such as nasolabial folds, crow's feet, and midface volume.
We’ll be back soon next month with more updates on medical device clinical trial approvals and other valuable news ๐
โถ References
Shin, Hyewon, Juneyoung Lee, and Hyonggin An. "Simulation Study for Comparison between ITT and PP in Matched Pair Noninferiority Clinical Trials." Journal of Health Informatics and Statistics Korea Vol 36 No.2 (2011)