Clinical trial: NCT06435286
Section: Alternatives
Subsections: Alternatives

The following alternative procedures or treatments are available if you choose not to participate in this study: If you decide not to participate in the study, you will still receive the standard of care, and your scheduled endoscopy procedure will proceed as planned. Your medical care will remain the same, regardless of your decision to participate or not in the study. It is entirely your choice, and declining participation will not affect the quality or nature of the care you receive during the routine endoscopy ..
Clinical trial: NCT06435286
Section: Confidentiality
Subsections: Sharing And Future Research Studies With Identifiable Private Information

Your identifiable private information collected as part of this research, even if the identifiers are removed, will not be used or distributed for future research studies.
Clinical trial: NCT06435286
Section: Participant's Rights
Subsections: Subject'S Rights

Your signature on this consent form means that you have received the information about this study and that you agree to volunteer for this research study. You will be given a copy of this signed form to keep. You are not giving up any of your rights by signing this form. Even after you have signed this form, you may change your mind at any time. Please contact the study staff if you decide to stop taking part in this study.  
H-53483- EFFECTIVENESS AND PERFORMANCE OF A MOBILE, AUTOMATED, OPTICAL
BIOPSY TECHNOLOGY FOR ESOPHAGEAL CANCER SCREENING: A CLINICAL STUDY IN
BRAZIL AND THE UNITED STATES
If you choose not to take part in the research or if you decide to stop taking part later, your benefits and services will stay the same as before this study was discussed with you. You will not lose these benefits, services, or rights. The investigator, SHARMILA ANANDASABAPATHY, and/or someone he/she appoints in his/her place will try to answer all of your questions. If you have questions or concerns at any time, or if you need to report an injury related to the research, you may speak with a member of the study staff: SHARMILA
ANANDASABAPATHY at 713-798-8105 during the day and ADRIANNA MALIGA at 713-798-5987 after hours. Members of the Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals (IRB)
can also answer your questions and concerns about your rights as a research subject. The IRB office number is (713) 798-6970. Call the IRB office if you would like to speak to a person independent of the investigator and research staff for complaints about the research, if you cannot reach the research staff, or if you wish to talk to someone other than the research staff.  
H-53483- EFFECTIVENESS AND PERFORMANCE OF A MOBILE, AUTOMATED, OPTICAL
BIOPSY TECHNOLOGY FOR ESOPHAGEAL CANCER SCREENING: A CLINICAL STUDY IN
BRAZIL AND THE UNITED STATES
Signing this consent form indicates that you have read this consent form (or have had it read to you),
that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study. You will receive a copy of this signed consent form.  
| Subject                                    | Date   |
|--------------------------------------------|--------|
| Investigator or Designee Obtaining Consent | Date   |
| Witness (if applicable)                    | Date   |
| Translator (if applicable)                 | Date   |
Clinical trial: NCT06435286
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Potential Risks And Discomforts|Research Related Injury

1. Allergic Reaction (Anaphylaxis): You may have a severe allergic reaction to the Proflavine contrast dye, resulting in difficulty breathing and a drop in blood pressure. If such a reaction occurs, we have procedures to treat you in the endoscopy room. 2. Specimen Imaging Probe (AI-mHRME): You will have minimal to zero risks when we use the imaging probe during the endoscopy procedure. No risks are associated with using the imaging probe
(AI-mHRME).  
H-53483- EFFECTIVENESS AND PERFORMANCE OF A MOBILE, AUTOMATED, OPTICAL
BIOPSY TECHNOLOGY FOR ESOPHAGEAL CANCER SCREENING: A CLINICAL STUDY IN
BRAZIL AND THE UNITED STATES
3. Anesthesia: You may have additional risks due to the extended duration of sedation, potentially leading to decreased blood pressure. We have procedures to treat you in the endoscopy room. 4. Inhaling of Fluid into the Lungs (Aspiration) during Endoscopy: You may have a risk of lung inflammation if you inhale fluid in the lungs during the endoscopy procedure. While you are under anesthesia, we will implement safeguards to minimize the chances of this happening. We will meticulously monitor your breathing and vital signs for any alarming changes. If you experience any symptoms that the study doctor did not previously explain, you should notify the study team promptly. 5. Pregnancy: If you are pregnant (determined by urine test before the endoscopy procedure), you will be excluded from both the study and the endoscopy procedure. Standard hospital protocol includes a urine pregnancy test for all patients of child-bearing age before endoscopy. Insufficient information is available regarding the use of Proflavine in pregnancy, and drugs can have harmful effects on the fetus. 6. Loss of Privacy: There is the potential for the loss of confidentiality. You will give consent on the day of your endoscopy procedure in a private area. We will collect only essential information from you that is required for a standard surveillance endoscopy. You will be assigned an ID number for all forms, images, and communications to maintain anonymity. All your data will be coded and de-identified using this assigned study ID. Any documents with your Protected Health Information (PHI) will be redacted before being sent for data monitoring/entry. All your PHI that we collect for the study will be stored securely. We will minimize intrusion on your privacy. The only additional times we will contact you will be 7 days after the endoscopy procedure and one year later to follow up on your symptoms and check for adverse events. Only the study coordinator or the Principal Investigator will contact you for follow-up.  
Your participation in the study will only be discussed between you and the study team. The risk to you is minimal for the post hoc image analysis project. Privacy concerns are addressed by assigning a unique, random ID to you and other participants, and we will not store identifying information.  
There may be unknown risks or discomforts involved. Study staff will update you in a timely way on any new information that may affect your decision to stay in the study. There is a small risk for the loss of confidentiality. However, the study personnel will make every effort to minimize these risks.

All research activities will take place on-site in a hospital setting. In the event of any injuries, they will be managed according to the standard of care in a hospital setting. The research personnel will try to minimize, control, and treat any complications that may arise during this research. If you experience an injury related to this study, the medical care you receive will be your responsibility or covered by your insurance, similar to any other medical care. The research team is committed to providing appropriate medical attention and managing adverse events following established medical practices. If you have any concerns or questions about this aspect of the study, feel free to discuss them with the study coordinator or your healthcare provider.  
Research personnel will try to reduce, control, and treat any complications from this research. If you are injured because of this study, you will receive medical care that you or your insurance will have to pay for just like any other medical care.
Clinical trial: NCT06435286
Section: Procedures
Subsections: Procedures

The research will be conducted at the following location(s):
Baylor College of Medicine, Baylor St. Luke's Medical Center (BSLMC), and HCHD: Harris County Hospital District Ben Taub.  
In Brazil, the research will be conducted at the following location(s): Instituto do Câncer do Estado de São Paulo (ICESP), São Paulo, Brazil; and Barretos Cancer Center Hospital de Amor (BCC),
Barretos, Brazil. 1. Routine Endoscopy: As part of your standard care for esophageal cancer, we will collect images of
Clinical trial: NCT06435286
Section: Purpose of Research
Subsections: Purpose

This study aims to enhance and assess the impact of an artificial intelligence mobile high-resolution microendoscope (AI-mHRME) on diverse populations in the USA and Brazil. For this study, AI
technology is a computer software program that can perform human tasks. It was developed to help look at the cells in the esophagus and tell doctors if any cells look abnormal. We plan to enroll patients scheduled for routine endoscopy who are either under surveillance or screening for ESCN. The AI-mHRME probe will capture images of the esophagus in abnormal areas, and the doctor's diagnosis during the procedure will be determined. These images will be compared to the pathology results from collected biopsies. A challenge in the community is that most doctors are unfamiliar with interpreting these microscopic HRME images. The research aims to test a computer software program designed to interpret these HRME images, aiding doctors in diagnosing high-risk patients undergoing LCE followed by HRME for esophageal cancer screening. We will compare the results of LCE to HRME and clinical interpretation.  
The goal is to develop a precise and swift diagnosis, enabling the use of this low-cost technology in low-resource or community settings and improving the care of patients at risk of developing esophageal cancer.