Eye Gaze Guidance Evaluation in Phantoms
Phase: NA
Conditions: Kidney Stones
Sponsor: Vanderbilt University Medical Center

VUMC Institutional Review Board 
Informed Consent Document for Research 
 
Study Title: 
Development and Validation of a Gaze-based Training for Endoscopic Kidney Stone 
Surgery 
Version Date: 
PI: 
2/21/2025 
Dr. Nicholas Kavoussi 
  
 
 
 
 
1
This box is for 
IRB USE ONLY 
Do not edit or delete 
 
 
Name of participant: __________________________________________ Age: ___________ 
 
The following is given to you to tell you about this research study.  Please read this form with care and 
ask any questions you may have about this study.  Your questions will be answered.  Also, you will be 
given a copy of this consent form.   
 
 
 
Key information about this study:  
You are being asked to take part in this research study because you have selected ureteroscopy 
for the surgical treatment of your patient’s kidney stone(s). We are conducting this study to gather 
clinical information to help understand the benefits of optical tracking on surgical education. 
Currently, there are no objective means of evaluating surgical residents. This study will passively 
provide information on expert surgeon gaze information to surgical residents during kidne y stone 
surgery. There are no additional risks to the procedure. There is no compensation for 
participation in this study. The study will conclude after completing 10 separate kidney stone 
surgeries. 
 
 
 
You are being asked to take part in this research study because there are currently no objective metrics 
measuring surgical competency for kidney stone surgery. Optical tracking has shown to distinguish 
novice and expert surgeons in phantom models. Additionally, eye gaze information can be relayed to 
trainees to potentially improve surgical training. 
 
You do not have to be in this research study. You may choose not to be in this study and treat patients 
based on your professional recommendation.  You can stop being in this study at any time.  If we learn 
something new that may affect the risks or benefits of this study, you will be told so that you can decide 
whether or not you still want to be in this study. 
 
Key Information:  
The first section of this document contains some key points that the research team thought you 
would find important. The study is described in more detail after this section. If you do not 
understand something, please ask someone.  
Detailed Information: 
The rest of this document includes detailed information about this study (in addition to the 
information listed above). 
Date of IRB Approval: 05/28/2025
Date of Expiration: 05/27/2026

VUMC Institutional Review Board 
Informed Consent Document for Research 
 
Study Title: 
Development and Validation of a Gaze-based Training for Endoscopic Kidney Stone 
Surgery 
Version Date: 
PI: 
2/21/2025 
Dr. Nicholas Kavoussi 
  
 
 
 
 
2
This box is for 
IRB USE ONLY 
Do not edit or delete 
 
Side effects and risks that you can expect if you take part in this study: 
None.  There may be unknown or unanticipated adverse effects. 
 
Good effects that might result from this study: 
The benefits to science and humankind that might result from this study: We may find that optical 
tracking and gaze information improves surgical education for kidney stones and improves competency 
for stone treatment, which would have a broad impact on patients. 
 
Procedures to be followed: 
For expert surgeons: We will be collecting intraoperative eye gaze data during ureteroscopy. We may be 
displaying that data as a pointer for the resident to during the surgery. We plan on obtaining data over 
10 cases. The eye gaze data will be analyzed postoperatively. 
 
For resident surgeons:  As a resident, we will be collecting intraoperative eye gaze data during 
ureteroscopy. You will be randomized to whether or not you will have access to the expert surgeon’s 
eye gaze information in the form of a pointer during the surgery.  The eye gaze data will be analyzed 
postoperatively. You will also be asked to fill out a NASA- Task Load Index form at the conclusion of each 
surgery. 
 
Payments for your time spent taking part in this study or expenses: 
You will receive no compensation for your participation in this study. 
 
Costs to you if you take part in this study: 
There is no cost to you for taking part in this study. 
 
Payment in case you are injured because of this research study: 
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the 
tests or treatments that are done for research, then you and/or your insurance will not have to pay for 
the cost of immediate medical care provided at Vanderbilt to treat the injury. 
 
There are no plans for Vanderbilt to pay for any injury caused by the usual care you would normally 
receive for treating your illness or the costs of any additional care. There are no plans for Vanderbilt to 
give you money for the injury. 
 
 
 
 
Date of IRB Approval: 05/28/2025
Date of Expiration: 05/27/2026

VUMC Institutional Review Board 
Informed Consent Document for Research 
 
Study Title: 
Development and Validation of a Gaze-based Training for Endoscopic Kidney Stone 
Surgery 
Version Date: 
PI: 
2/21/2025 
Dr. Nicholas Kavoussi 
  
 
 
 
 
3
This box is for 
IRB USE ONLY 
Do not edit or delete 
 
Who to call for any questions or in case you are injured: 
If you should have any questions about this research study or if you feel you have been hurt by being a 
part of this study, please feel free to contact Nicholas Kavoussi at 615-343-1317. 
 
For additional information about giving consent or your rights as a person in this study, to discuss 
problems, concerns, and questions, or to offer input, please feel free to call the VUMC Institutional 
Review Board Office at (615) 322-2918 or toll free at (866) 224-8273. 
 
Reasons why the study doctor may take you out of this study:  
You may be withdrawn from the study for the following reasons: 
- 
You elect to treat the stones via an alternant surgical technique. 
- 
If it is in your best interest. 
- 
If you don’t follow the study procedures 
- 
If the study is stopped. 
You may also be withdrawn from the study if you do not follow the instructions given to you by the 
study personnel. 
 
What will happen if you decide to stop being in this study? 
If you decide to stop being part of the study, you should tell the study principal investigator. 
 
Confidentiality: 
Research records will be kept confidential to the extent allowed by law. All study personnel are trained 
in procedures to ensure patient privacy and confidentiality according to the HIPAA privacy rule. Your 
study records include information that identifies you and that is kept in research files. We will try to 
keep this information confidential, but we cannot guarantee it. The data will be stored in a password-
protected database with limited access. If data from this study are to be published or presented, we will 
first take out the information that identifies you. 
This study may have some support from the National Institutes of Health (NIH). If so, your study 
information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to 
refuse to give out your information even if requested using legal means. 
It does not protect information that we have to report by law, such as child abuse or some infectious 
diseases. The Certificate does not prevent us from disclosing your information if we learn of possible 
harm to yourself or others, or if you need medical help. 
Date of IRB Approval: 05/28/2025
Date of Expiration: 05/27/2026

VUMC Institutional Review Board 
Informed Consent Document for Research 
 
Study Title: 
Development and Validation of a Gaze-based Training for Endoscopic Kidney Stone 
Surgery 
Version Date: 
PI: 
2/21/2025 
Dr. Nicholas Kavoussi 
  
 
 
 
 
4
This box is for 
IRB USE ONLY 
Do not edit or delete 
 
 
 
Disclosures that you consent to in this document are not protected. This includes putting research data 
in the medical record or sharing research data for this study, future research, or insurance purposes. 
Disclosures that you make yourself are also not protected. 
Privacy: 
To protect your privacy, we will not release your name. 
 
Study Results: 
Study results can be disclosed to you if you request once all data has been analyzed. 
 
If you decide not to take part in this research study, it will not affect your treatment, payment or 
enrollment in any health plans or affect your ability to get benefits. You will get a copy of this form after 
it is signed. 
 
Do you have to sign this Authorization? 
You do not have to sign this Authorization, but if you do not, you may not join the study. 
 
How long will your information be used or shared? 
Your Authorization for the collection, use, and sharing of your information does not expire.  Additionally, 
you agree that your information may be used for similar or related future research studies. 
 
What if you change your mind? 
You may change your mind and cancel this Authorization at any time.  If you cancel, you must contact the 
Principal Investigator in writing to let them know by using the contact information provided in this consent 
form.  Your cancellation will not affect information already collected in the study, or information that has 
already been shared with others before you cancelled your authorization. 
 
 
 
If you decide not to take part in this research study, it will not affect your treatment, payment or 
enrollment in any health plans or affect your ability to get benefits. You will get a copy of this form 
after it is signed. 
 
Date of IRB Approval: 05/28/2025
Date of Expiration: 05/27/2026

VUMC Institutional Review Board 
Informed Consent Document for Research 
 
Study Title: 
Development and Validation of a Gaze-based Training for Endoscopic Kidney Stone 
Surgery 
Version Date: 
PI: 
2/21/2025 
Dr. Nicholas Kavoussi 
  
 
 
 
 
5
This box is for 
IRB USE ONLY 
Do not edit or delete 
 
STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY 
 
I have read this consent form and the research study has been explained to me verbally.  All my 
questions have been answered, and I freely and voluntarily choose to take part in this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
Signature of patient/volunteer 
 
 
Consent obtained by: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name and Title 
 
Time: ______________ 
Date of IRB Approval: 05/28/2025
Date of Expiration: 05/27/2026