SBIR-STTR Award

Colonoscope Force Monitor
Award last edited on: 3/21/13

Sponsored Program
SBIR
Awarding Agency
NIH : NIDDK
Total Award Amount
$4,285,698
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Armen Sarvazyan

Company Information

ARTANN Laboratories Inc (AKA: Artann Corporation)

1459 Lower Ferry Road
West Trenton, NJ 08618
   (609) 883-0100
   artann@artannlabs.com
   www.artannlabs.com
Location: Single
Congr. District: 12
County: Mercer

Phase I

Contract Number: 1R43DK068936-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2004
Phase I Amount
$80,193
Several million screening, diagnostic and therapeutic colonoscopies are performed each year in the U.S. hospitals and ambulatory surgery centers. The application of force to the colon and its anatomic attachments can be painful and excessive force can lead to perforation. There is significant variation in the forces applied and the reduction in this variation in technique and the characterization of effective, less forceful insertion methods will lead to more uniform training, improved continuing education and safer colonoscopy with less anesthesia. The long-term goal of this project is to develop a Colonoscopy Force Monitor (CFM), a handheld force measuring attachment mounted on the colonoscope tube. This device is designed to be easy to use, inexpensive to manufacture and result in less painful and safer colonoscopies. The objectives of Phase of this project are to built and test the CFM prototype, to demonstrate that CFM has the potential to improve the quality of colonoscopy by training unskilled operators, to correctly and safely conduct colonoscopy and to improve the skill level of experienced colonoscopists. We will demonstrate feasibility with a prototype CFM on an existing colon phantom model. Significant commercial opportunity exists to provide an effective, low-cost method to define best practices in colonoscopy and to implement these practices as part of training, ongoing education and quality assurance.

Thesaurus Terms:
biomedical equipment development, biomedical equipment safety, biophysics, clinical biomedical equipment, endoscopy, gastrointestinal imaging /visualization, monitoring device injury prevention, medical complication, portable biomedical equipment bioengineering /biomedical engineering, bioimaging /biomedical imaging, phantom model

Phase II

Contract Number: 2R44DK068936-02A1
Start Date: 8/1/04    Completed: 5/31/09
Phase II year
2007
(last award dollars: 2013)
Phase II Amount
$4,205,505

The goal of this project is to develop a Colonoscopy Force Monitor (CFM), a handheld attachment mounted on the colonoscope shaft which provides a physician with real-time feedback on the force and torque applied during colonoscopy. The CFM is designed to improve the training of endoscopists, establish best practices for performing colonoscopy by quantitative characterization of expert's skill, and enhance colorectal cancer screening procedures by making them safer and more comfortable. Improved training and development of best practices will contribute to the safety and effectiveness of colorectal cancer screening. In addition, the use of CFM could reduce or, under some circumstances, eliminate the use of deep sedation for colonoscopy, and lessen the overall cost of the exam. The CFM prototype development performed to date has advanced beyond the original objectives of Phase I. Three generations of the CFM-a prototypes were designed, built, and validated in phantom testing by experienced endoscopists. The objectives of Phase II of this project are to build and test the CFM a-prototype. The CFM performance will be first assessed in colonoscopy simulator tests. Then, clinical studies will be conducted simultaneously at two partnering organizations: Montefiore Medical Center, Bronx, NYC, and the Institute for Clinical Research at the Veterans Affairs Medical Center, Washington, D.C. At the end of Phase II, the full-performance, preproduction prototype of CFM will be developed, a clinical trial of the effect of CFM on training and ongoing education will be performed, and necessary engineering documentation will be prepared in accordance with regulatory requirements. Colonoscopy Force Monitor (CFM) is a handheld device measuring and displaying the torque and push/pull forces applied by a physician during colonoscopy. The technology is designed to improve colonoscopy training, establish best practices, and improve colorectal cancer screening procedures by making them safer and more comfortable.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.