Investigator-
Initiated Study

Strategic Focus

Motus GI believes that clinical research data is generated in many important avenues such as sponsored trials, investigator-initiated studies (IIS) and real-world evidence endeavors. Each avenue contributes in different ways and specifically, investigator-initiated research allows for industry and the medical community to pursue equally important ideas in a collaborative environment. The value of the scientific research produced by investigators, is key to complementing sponsored research and Motus GI is committed to supporting investigator led initiatives.
 

Motus GI defines an IIS as a clinical study conceptualized, developed and executed by an independent third-party sponsor. Each IIS must be unsolicited, and conducted without the participation of Motus GI and using the highest level of scientific rigor. 

Additional Resources

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IIS Application Form
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ClinicalTrials.gov
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Good Clinical Practice (GCP)
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AdvaMed Code of Ethics

Motus GI Strategic Focus for Pure-Vu EVS:

 

Inpatient Use

Pure-Vu EVS training and implementation process

Comparison to standard-of-care cleansing protocol

  • Patient outcomes
  • Time to diagnosis
  • Health economics
  • Bowel preparation quality (i.e., BBPS)
  • LOS
Diagnostic yield—LGIB
Impact on 30-day re-admit rates for LGIB and bleeding recurrence
Clinician satisfaction & usability
Impact on bowel prep regimen

Impact of Pure-Vu EVS on hospital efficiency

  • LGIB
  • Colorectal surgery
  • Transplant
    colonoscopy workup
 

Outpatient Use

Comparison to standard of care

  • Patient outcomes
  • Surveillance intervals
  • Health economics
  • Adenomas per colonoscopy
    and/or ADR
  • BBPS
Use in patients that are high risk for IBP or poor visualization
Pure-Vu use in CRC screening populations
Use of Pure-Vu in vulnerable patients
Impact of Pure-Vu on IBP related OC cancellation
Pure-Vu training and implementation process
Impact on bowel prep regimen
Pure-Vu use with other technologies (AI or others)
Clinician satisfaction & usability

The Overarching Principles Governing the Evaluation of IIS Include That:

  • The IIS proposal received is unsolicited and aligned with Motus GI Strategic Areas of Interest.
  • The IIS proposal addresses a valid scientific question and the data generated by the IIS will complement existing body of evidence.
  • The IIS to be conducted is on label and of robust and ethical design.

Send Us Your
Proposal

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