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.

Temporary Program Pause

OCA will pause review of new proposals for financial support for IITs. Requests for in-kind support will continue to be considered.

IIT Committee

The IIT Committee makes decision 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
Research coordinator cost
Data management expenses
IRB review fees
Equipment/supplies

The IIT Committee does not support:

Educational and training activities
Labor cost 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

Bladder Cancer

Visualization of bladder tumor, especially CIS, and long-term outcomes (e.g. recurrence) using NBI™ technology of the VISERA ELITE™ II system.

Urolithiasis

Clinical performance of SOLTIVE™ SuperPulsed Laser (optimal laser setting for various clinical settings)
Clinical outcomes and healthcare economics of SOLTIVE™ SuperPulsed Laser compared to HoLEP and Thulium YAG
Treatment outcomes of SOLTIVE™ SuperPulsed Laser in patients with stones greater than 2cm

Benign Prostatic Hyperplasia (BPH)

Clinical performance of SOLTIVE™ SuperPulsed Laser (optimal laser setting for various clinical settings)
Treatment outcomes of SOLTIVE™ SuperPulsed Laser in patients on anticoagulant medication
Clinical outcomes of SOLTIVE™ SuperPulsed Laser compared with HoLEP and/or ThuLEPg
Clinical performance of the iTind™ device in office based procedures

Gynecology

Uterine Fibroid

Treatment outcomes of hysteroscopic resection using Olympus PLASMA bipolar resection electrodes compared with monopolar electrodes
Safety, efficacy, and cost-effectiveness of PLASMA hysteroscopic resection electrodes compared with hysteroscopic tissue removal devices (a.k.a. hysteroscopic morcellators), in Type 1 and Type 2 fibroids avoiding need for multistep procedures

Office Hysteroscopy

Clinical performance of Olympus products in office settings

Gastroenterology (Upper)

GERD

Endoluminal treatment outcomes of Olympus products

General Surgery

Colon, Liver and Ovarian Cancer

Efficacy of Intraoperative Endoscopy (IOE)
Clinical/Economical value of IOE
Efficacy for 5mm 4K Telescope of VISERA 4K UHD System
Efficacy of ENDOEYE 3D Imaging System
3D vs 2D laparoscopy Clinical/Economical value
Efficacy of ENDOEYE FLEX for articulation

Neurosurgery and Others

Brain Cancer, Head & Neck Cancer and Breast Cancer

Utilization of ORBEYE Exoscope
Efficacy of ORBEYE 4K-3D Visualization
Comparison of ORBEYE 4K-3D with Conventionaland/or Similar technologies
Comparison of ORBEYE Smart Operating Room with Conventional style
Clinical/Economical impact of ORBEYE for Optimized Components/Room

Respiratory

General

Clinical outcomes of Olympus respiratory products
Patient screening and selection methods for procedure eligibility related to Olympus respiratory products
Diagnostic and screening solutions that analyze and/or determine patient total lung health

Lung cancer

Clinical outcomes especially diagnostic yield of hybrid bronchoscope (BF-MP190F) combined with PeriView FLEX
Clinical outcomes of ultrasound bronchoscope (BF-UC190F)
Effectiveness of insertion tube rotation function and 210-degree angulation in clinical settings (BF-XP190, BF-P190, BF-Q190, BF-H190, BF-MP190F)
Clinical outcomes related to Navigation-guided percutaneous approaches to TTNA
Clinical outcomes, cost savings and/or economic impact related to single-setting single episode of care approaches to lung cancer diagnosis and staging utilizing EBUS-TBNA, Peripheral Bronchoscopy, EMN, and/or EMN-guided TTNA
Clinical outcomes related to the BF-UC190F EBUS Bronchoscope
Clinical outcomes, especially diagnostic yield, of EMN with the SPiN Thoracic Navigation System
Clinical outcomes related to Fine Needle Biopsy with the ViziShot 2 FLEX 19 G EBUS-TBNA needle

Endobronchial valves

Response and/or adverse event predictors for emphysema and air leaks
Patient selection or procedure modification that impacts benefit and or adverse events for endobronchial valves in emphysema and/or air leaks
Financial impact of treatment with endobronchial valves in emphysema and/or air leaks

ENT

Benign lesions (vocal fold nodule/polyps, Reinkes edema, Hyperkeratosis, Granuloma, Inflammation, Papilloma), pre-malignant lesion (Mild / moderate /severe dysplasia) and malignant lesions in oral cavity, larynx, oropharynx, hypopharynx and nasopharyngeal

Efficacy and performance of NBI in visualizing the capillary network and mucosal morphology

Submission Process

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: 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: 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: 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: Conduct Study

The investigator is responsible for obtaining the Investigational Review Board (IRB) / Ethical 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: 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 of the Americas: Provides financial support and/or devices as outlined in the IIT agreement.

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

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/shipment of product?

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 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 my study is delayed or has trouble with enrollment?

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.

Should I register my 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 occurred 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.

Can OCA control or prevent me from publishing results and do I need to inform OCA?

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.