Medical Device Development Clinical Trial

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A Medical Device Development Clinical Trial is a Clinical Trial that is conducted to test and help develop a new medical device.



References

2022

2019

2018

  1. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69, 89–95 (2001).
  2. Byrom, B. et al. Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making: recommendations from the ePRO Consortium. Value Health (in press).

2017

Device type Data collected Examples
Wrist worn Actigraphy, HR (Heart Rate), BP (Blood Pressure), EDA (Electrodermal activity) Actiwatch Spectrum by Phillips, ActiGraph Link by ActiGraph, E4 by Empatica, ViSi Mobile by Sotera Wireless
Skin patch ECG (Electrocardiography), actigraphy, skin temperature BioStampRC by MC10, HealthPatch by Vital Connect, BodyGuardian by Preventice
Cuffs BP, HR Intellisense Digital BP Monitor by Omron Healthcare
Finger worn HR, SpO2 iSpO2 Pulse Oximeter by Massimo
Clothing embedded sensors HR, HRV (Heart Rate Variability), ECG, Breathing Rate, actigraphy Smart shirts by Hexoskin
Headbands EEG (Electroencephalogram), EMG (Electromyography) EMOTIV EPOC by Emotiv, 4D FORCE by 4D FORCE
Table 1: Examples of wearable sensors.

2016

2013

2004


  1. Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP. Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med1994;330:403-8. doi:10.1056/NEJM199402103300607 pmid:8284007.
  2. Barkun JS, Aronson JK, Feldman LS, et al. Balliol Collaboration. Evaluation and stages of surgical innovations. Lancet2009;374:1089-96. doi:10.1016/S0140-6736(09)61083-7 pmid:19782874.
  3. Drolet BC, Lorenzi NM. Translational research: understanding the continuum from bench to bedside. Transl Res2011;157:1-5. doi:10.1016/j.trsl.2010.10.002 pmid:21146144.
  4. Thompson M, Heneghan C, Billingsley M, Cohen D. Medical device recalls and transparency in the UK. BMJ2011;342:d2973. doi:10.1136/bmj.d2973 pmid:21572136.
  5. Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med2014;174:1781-7. doi:10.1001/jamainternmed.2014.4193 pmid:25265047.
  6. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med2011;171:1006-11. doi:10.1001/archinternmed.2011.30 pmid:21321283.