Olympus America

Investigator Initiated
Trial (IIT) Program

Olympus Corporation of the Americas (OCA) is committed to advancing medical and scientific knowledge about Olympus products and contributing to the improvement of patient care by supporting investigator sponsored original research.

IIT Committee

The IIT Committee makes decisions pertaining to the support of IITs in the United States.

The IIT Committee assesses all requests for scientific merit and strategic interest and does not make decisions based upon past, present or future opportunities to generate business or goodwill from investigators.

Types of Studies Supported

The IIT Committee accepts the following types of proposals:
  • Research related to Olympus’ published Research Areas of Interest
  • Approved label studies using cleared/approved Olympus Products
The IIT Committee does not accept the following types of proposals:
  • Non-human subject studies
  • Studies using investigational devices or off-label uses
  • Research topics outside Olympus’ published Research Areas of Interest

Types of Support Provided

Financial support and/or Olympus devices may be provided depending on the type of research.

The IIT Committee currently supports:
  • Subject-related cost
  • Data management expenses
  • IRB review fees
  • Equipment/Supplies (In-Kind Support)
The IIT Committee does not support:
  • Educational and training activities
  • Salary/wage costs of investigators
  • Purchase of capital equipment unrelated to the study or that would generate revenue
  • Travel to conferences to present study results
  • Manuscript writing
  • Publication preparation and submission
  • Idea or protocol development

The investigator and/or investigator’s institution assumes the roles and responsibilities of the study sponsor, including compliance of all regulatory requirements.


Research Areas of Interest

Urology
Urology

Bladder Cancer

  • Detection of bladder tumor (especially CIS) using NBI of VISERA ELITE II

Urolithiasis

  • Clinical performance of SOLTIVE (optimal laser setting for various clinical settings)
  • Clinical outcomes and healthcare economics of SOLTIVE compared with Ho:YAG laser
  • Treatment outcomes of SOLTIVE in patients with stones greater than 2cm

Benign Prostatic Hyperplasia (BPH)

  • Clinical performance of SOLTIVE (optimal laser setting for various clinical settings)
  • Treatment outcomes of SOLTIVE in patients on anticoagulant medication
  • Clinical outcomes of SOLTIVE compared with HoLEP and/or ThuLEP
Gynecology
Gynecology

Uterine Fibroid

  • Treatment outcomes of PLASMA compared with monopolar especially in patients with large and/or type 2 uterine fibroid
  • Cost-effectiveness of PLASMA compared with mechanical morcellators

Office Procedure

  • Clinical performance of Olympus products in office settings
Gastroenterology
Gastroenterology (Upper)

GERD

  • Endoluminal treatment outcomes of Olympus products
Respiratory
Respiratory

Lung Cancer

  • Clinical outcomes especially diagnostic yield of hybrid bronchoscope (BF-MP190F) combined with PeriView FLEX
  • Clinical outcomes of ultrasound bronchoscope (BF-UC190F/UC290F)
  • Effectiveness of insertion tube rotation function and 210 degree angulation in clinical settings (BF-XP190/290, BF-P190/290, BF-Q190/290, BF-H190/290, BF-MP190/290)
Neurosurgery
Neurosurgery

Brain and Spinal Cord Tumor Surgery

  • Utilization of exoscope (ORBEYE)

Submission Process

Step 1
Step 1: Review IIT Program Overview and Research Areas of Interest

Please note, requests must align with Olympus' published Research Areas of Interest

Step 2
Step 2: Submit Proposal

Fill out “IIT Request Form” and prepare documents required for proposal evaluation and funding review. Submit “IIT Request Form” and all the documents to ocaiitsupport@olympus.com.

Required Documents:

  • Draft protocol or protocol synopsis
  • Sponsor-Investigator’s curriculum vitae (signed and dated)
  • Copy of Sponsor- Investigator’s medical license
  • Curriculum vitae and medical license for Sub-investigators, if applicable
  • Financial disclosure form

DOWNLOAD IIT REQUEST FORM

Step 3
Step 3: IIT Committee Review

Once complete, each eligible proposal will be assessed by the IIT Committee. The IIT Committee carefully reviews the details of the proposal including scientific soundness, alignment with research area of interest, regulatory compliance, and budget alignment with Fair Market Value (FMV).

The IIT Committee reserves the right to deny proposals or to adjust support levels in accordance with its direction.

Step 4
Step 4: Contracting

If support is approved, an IIT agreement is coordinated between Olympus Corporation of the Americas and the investigator’s institution.

The agreement documents the final protocol and milestones and must be executed prior to the start of the study.

Step 5
Step 5: Conduct Study

The investigator is responsible for obtaining the Investigational Review Board (IRB) / Ethics Committee (EC) approval, conducting study, and providing regular progress reports to OCA.

Support will be provided upon the achievement of milestones as outlined in the IIT agreement.

Step 6
Step 6: Completion and Final Deliverable

Upon completion of the study; the investigator will submit the final deliverable to OCA as outlined in the IIT agreement and the project will be closed out by OCA.


Frequently Asked Questions

Program Overview

What are the roles and responsibilities of an investigator participating in the OCA IIT Program?

An investigator is a single individual or institution that takes the roles and responsibilities of both a study sponsor and an investigator.

Supporter, Olympus Corporation of the Americas: Provides financial support and/or devices as outlined in the IIT agreement.

Sponsor- Investigator, Physician/Institution: Has authority and controls over the study, including document management, data management, data analysis, publication, regulatory action, etc.

Investigator, Sub- Investigator, Physician: Initiates and conducts the study according to a defined protocol and in compliance with Good Clinical Practice (GCP) guidelines.

Submission, Review, and Contracting

How long does the review process take?

A response is provided to the investigator within 60 days. If a submission is incomplete and/or missing required information, the review process would take longer.

What is the review criteria?

  • Scientific soundness
  • Novelty of research question
  • Strategic alignment
  • Investigator’s qualification
  • Regulatory status
  • Appropriateness of budget

What information is required to submit a proposal?

  • Contact information
  • Details about the proposed study (protocol synopsis or full protocol)
  • Detailed request for support
  • Research experience
  • Investigator(s) CV (s)
  • Current medical license
  • Financial Disclosure Form

What is required for preparation of the contract?

  • The finalized protocol
  • The finalized study budget

Study Start-up and Study Management

Does OCA require IRB/EC protocol approval?

OCA must receive a copy of the Investigational Review Board (IRB) or Ethics Committee (EC) protocol approval letter before any support can be provided. If a waiver is granted by the IRB/EC, please submit a copy of waiver documentation.

What is required before the first study payment or equipment/supplies (In-Kind Support) can be provided?

  • IIT agreement signed and dated by all parties
  • IRB/EC approval
    • All payments are based on milestones outlined in the IIT agreement. Start-up payment may or may not be included as a milestone.

What is required to be submitted during the study period?

Regular progress reports are required as outlined in the IIT agreement to document study progress and determine whether payment milestones have been achieved. If reports are not received in a timely manner as outlined in the IIT agreement, OCA may decide to discontinue support.

What happens if the study is delayed or has enrollment challenges?

Please inform OCA of any delays to the study. If the study requires protocol changes, the investigator will be required to provide a report to OCA that summarizes the proposed changes, the cause of the delay, provides a justification of the change, and an explanation of what can be done to get the study back on track.

The IIT Committee will review the changes and make a decision on remedial action.

Must the sponsor-investigator register the study online?

Yes. The sponsor-investigator is responsible for registering the study. Moreover, in alignment with the International Committee of Medical Journal Editors (ICMJE), OCA requires that the study be registered before the sponsor-investigator enrolls the first subject.

The online clinical trial registration system may be accessed at: www.clinicaltrials.gov

Who is responsible for reporting adverse events that occur in the study?

The sponsor-investigator is responsible for reporting adverse events that occurr in the study as required by applicable laws and regulations.

The FDA defines specific responsibilities for investigators and sponsors.

Must I inform OCA of publications and can OCA prevent me from publishing study results?

Please notify OCA of intent to submit an abstract or manuscript as outlined in the IIT Agreement. OCA requires review of all publications prior to public disclosure to ensure technical accuracy and to protect our intellectual property.  OCA will not prevent publication of results, but is permitted to request reasonable redrafting to protect proprietary information.