Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
Phase: PHASE1
Conditions: Functional Dyspepsia
Sponsor: MetroHealth Medical Center

 
 
 
 
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PROTOCOL TITLE: 
Transcutaneous electrical acustimulation in automatic synchronization with 
breathing for treating functional dyspepsia: A phase I feasibility trial 
PRINCIPAL INVESTIGATOR: 
Name: Michael Kurin 
Department: Department of Gastroenterology 
Telephone Number: (216)7783207 
Email Address: mkurin@metrohealth.org 
VERSION NUMBER/DATE: 
Version 1.0 02/07/2024 
Version 2.0 05/10/2024 
Version 3.0 3/07/2025 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
2 
Adding option for subjects to complete 
questionnaires outside of study visit via email 
or text message link from REDCap after 
consenting in person 
Y 
2 
3 
Changed patient payment for the study from 
$150 to $0. Also updated expected enrollment 
and study completion dates. 
Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 4 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 8 
5.0 
Study Intervention/Investigational Agent ................................................................ 9 
6.0 
Procedures Involved*............................................................................................. 14 
7.0 
Data and Specimen Banking* ................................................................................ 17 
8.0 
Sharing of Results with Subjects* ......................................................................... 18 
9.0 
Study Timelines* ................................................................................................... 18 
10.0 Inclusion and Exclusion Criteria* .......................................................................... 18 

 
 
 
 
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11.0 Vulnerable Populations* ........................................................................................ 19 
12.0 Local Number of Subjects ..................................................................................... 19 
13.0 Recruitment Methods ............................................................................................. 20 
14.0 Withdrawal of Subjects* ........................................................................................ 20 
15.0 Risks to Subjects* .................................................................................................. 21 
16.0 Potential Benefits to Subjects* .............................................................................. 22 
17.0 Data Management* and Confidentiality ................................................................ 22 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 23 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 24 
20.0 Compensation for Research-Related Injury ........................................................... 25 
21.0 Economic Burden to Subjects ................................................................................ 25 
22.0 Consent Process ..................................................................................................... 25 
23.0 Process to Document Consent in Writing .............................................................. 26 
24.0 Setting .................................................................................................................... 27 
25.0 Resources Available............................................................................................... 27 
26.0 Multi-Site Research* ............................................................................................. 29 
 
 
 

 
 
 
 
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1.0 
Study Summary 
 
Study Title 
Transcutaneous electrical acustimulation in automatic 
synchronization with breathing for treating functional 
dyspepsia: A phase I feasibility trial 
Study Design 
Prospective, single-arm, open-label trial 
Primary Objective 
Assess the safety and usability of AutoSTEA treatment 
Secondary 
Objective(s) 
• Investigate symptom responses to AutoSTEA 
treatment; 
• Assess a diverse participant pool, especially 
overweight/obese and female patients 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
AutoSTEA treatment 
IND/IDE #  
 
Study Population 
Adult FD patients 
Sample Size 
Forty FD patients 
Study Duration for 
individual 
participants 
Two weeks 
Study Specific 
Abbreviations/ 
Definitions  
FD- Functional dyspepsia 
AutoSTEA- Transcutaneous electrical acustimulation in 
automatic synchronization with breathing 
TEA- transcutaneous electrical acustimulation (without 
synchronization with breathing) 
STEA- TEA manually synchronized with breathing 
 
 

 
 
 
 
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2.0 
Objectives* 
2.1 Describe the purpose, specific aims, or objectives. 
• Determine the device safety when self-administrated at home by 
patients.  
• Evaluate the device usability.  
• Assess symptom responses to AutoSTEA treatment. 
• Assess a diverse participant pool, especially overweight/obese and 
female patients.  
• Assess patients’ compliance of AutoSTEA treatment 
2.2 State the hypotheses to be tested. 
• AutoSTEA therapy is anticipated to be both safe and user-friendly, 
with the potential to effectively alleviate symptoms of FD. 
3.0 
Background* (Reference refer to Supplement 1) 
3.1 Describe the relevant prior experience and gaps in current 
knowledge. 
• FD affects up to 11.4% of the US population,1 impairs the quality of 
life, and poses a high annual cost of managing the disease, 
exceeding $18.4 billion in the US alone. 2 Due to the limited 
efficacy of existing treatments, FD symptoms are challenging to 
treat and fluctuate with time for most patients and become a lifelong 
medical burden. 3-6 
• Acupuncture, electroacupuncture, and needleless transcutaneous 
electrical acustimulation (TEA) have been applied to attenuate FD 
symptoms, and improve key pathophysiologies7-13, including 
impaired gastric accommodation, gastric pain/hypersensitivity, 
delayed gastric emptying, gastric dysrhythmia, and autonomic 
dysfunction. 
• TEA that manually synchronizes with respiration (STEA) (Fig. 1) recently 
emerged as a superior acute method over non-synchronized TEA in 
improving FD.14-16  
 
 

 
 
 
 
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Figure 1. Transcutaneous electroacupuncture that manually synchronizes 
with respiration (STEA) 
 
 
 
3.2 Describe any relevant preliminary data. 
• In two clinical studies, 15,16 Dr. Song has shown that acute STEA was more 
potent than both sham and non-synchronized TEA. Compared to TEA, 
STEA further increased the normal percentage of gastric slow waves by 
13%, enhanced vagal activity by 12%, and suppressed sympathetic activity 
by 12%. A clinical study by another group has demonstrated that acute 
STEA is superior to TEA in further decreasing overall dyspeptic scores by 
18%, with specific symptom improvements observed for postprandial 
fullness, bloating, and nausea. 14 These findings suggest that STEA 
provides more extensive relief of FD-related discomfort compared to TEA. 
Moreover, STEA was found to be more effective than TEA in ameliorating 
impaired gastric accommodation in response to a meal by 16%, possibly 
through the vagal pathway. Overall, the studies provide compelling 
evidence for the superiority of acute STEA over TEA for FD. 
• A prototype was made as shown in Fig. 2. 17 This version of the controller 
measures 120mm x 100mm x 30mm and weighs 228 grams, offering 
enhanced portability. The chest strip sensor is made with Velcro strip 
embedded with a strain-gauge force sensor, which is convenient for the 
users to wear and take off. 
 
 
Figure 2. Prototype: (a) Overview of the device; (b) Application testing 
 
• Benchtop experiments were conducted on three human users to verify the 
functionality and effectiveness of the AutoSTEA device. 17 The human 
users wore the respiration strip and sat in a comfortable chair, and the 
electrodes were connected with an artificial human impedance simulator. 
The testing was conducted for 5 minutes (about 75 cycles) for each user, 

 
 
 
 
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and each user repeated the testing three times. The results showed all the 
start points of the inhalation were identified. Fig. 3 shows the example 
result of one user. It demonstrated that the control system can synchronize 
respirations with neglectable delay, generate expected electrical 
waveforms, and provide a reliable function even with varying respiration 
cycles. 
 
Figure 3. Benchtop testing result 
3.3 Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how 
will it add to existing knowledge. 
Functional dyspepsia (FD) also termed non-ulcer dyspepsia, is a 
common stomach disorder characterized by postprandial fullness, 
early satiety, and epigastric discomfort without an organic cause. 18-21 
It affects up to 11.4% of the US population, 1 impairs the quality of 
life, and poses an annual management cost of over $18.4 billion in 
the US. 2 FD symptoms can be related to meals or unrelated, 
associated with impaired gastric accommodation, gastric 
hypersensitivity, delayed gastric emptying, gastric dysrhythmia, and 
autonomic dysfunction. 18,22,23 FD symptoms fluctuate over time and 
often become a lifelong medical burden for patients. 18 
Existing FD therapies primarily address symptoms, lose 
effectiveness over time, and carry substantial side effects. 18 These 
therapies include helicobacter pylori eradication, proton pump 
inhibitors (PPIs), histamine-2 receptor antagonists, antidepressants, 
and prokinetic agents. 18,24,25 Eradicating H. pylori may improve 
dyspeptic symptoms, but only one out of 14 treated patients 
responded positively. 7 While PPIs are moderately effective in 
symptomatic treatment by suppressing gastric acid production, they 
minimally affect FD's underlying pathophysiologies.4 
Antidepressants, considered when PPIs offer partial or no relief, 
improve symptoms for some patients, but studies on their 
pathophysiological effects are scarce, and significant side effects like 
drowsiness and impaired gut motor function occur. 5 Prokinetics can 
improve gastric motility but have limited effects on dyspeptic 
symptoms, and patients suffer from multiple side effects. 26 In 
summary, while various treatment options are available, their 

 
 
 
 
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therapeutic effects are limited and accompanied by multiple side 
effects. 3-5,26 In addition, there is a lack of integrative therapy that 
targets multiple pathophysiological mechanisms implicated in FD. 
STEA therapy for FD. Evolving from traditional needle 
acupuncture and electroacupuncture, TEA that is delivered at 
acupuncture points via surface skin electrodes becomes a treatment 
of interest for gastric motility disorders. 7-12 Recently, an even more 
effective method STEA is emerging. The preliminary clinical studies 
14-16 have demonstrated that the targeting performance of STEA is 
superior to that of TEA without synchronization to improve key FD 
pathophysiology, including amelioration of impaired gastric 
accommodation in response to a meal, normalization of gastric 
dysrhythmias, improvement of visceral hypersensitivity, and 
enhancement of vagal activity. No off-target mitigation/adverse 
effects of STEA were observed during these studies. 
Limitations of STEA. Current procedure for conducting STEA 
treatment is mostly based on patients' manual synchronization in 
which the patients need to feel the start of stimulation and adjust 
their respiration to follow the stimulation. 14-16 This manual 
synchronization can generate a considerable delay or error in the 
synchronization and result in patients' noncompliance with chronic 
therapy, significantly compromising the effectiveness of this method. 
A novel AutoSTEA device: To solve this issue and enhance the 
effectiveness of STEA in FD treatment, we have developed a novel 
non-invasive neuromodulation method, termed transcutaneous 
electrical acustimulation in automatic synchronization with breathing 
(AutoSTEA) (Fig 2), which automatically detects the user's 
respiration wave and synchronizes with the breath to deliver 
electrical stimulation at acupuncture points via surface skin 
electrodes (Fig. 3). 17 With this automated synchronization device, 
patients can inhale and exhale with an uninterrupted and normal 
respiration pace while receiving the TEA treatment, largely 
simplifying the treatment procedures, improving patients’ 
compliance, and enhancing the effectiveness of the method. 
Significance of the AutoSTEA therapy. (1) AutoSTEA reduces (1a) travel 
time and costs to acupuncture clinic, (1b) need for healthcare providers, and 
(1c) repeat procedure expenses, compared to traditional acupuncture/ EA. (2) 
AutoSTEA demonstrates superior therapeutic outcomes over non-
synchronized TEA. (3) Unlike manual STEA, AutoSTEA's automation 
ensures uninterrupted natural respiration during treatment, simplifying 
procedures and improving patient experience, compliance, and feasibility and 
effectiveness of chronic therapy. 

 
 
 
 
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Scientific contribution: This project's primary objective is to evaluate the 
usability and safety of AutoSTEA therapy as outlined in the Phase I proposal. 
Success in these areas will lay the groundwork for conducting a 
comprehensive multi-center efficacy study in the subsequent Phase II 
proposal.   
Clinical impact: AutoSTEA is expected to enhance and/or replace existing 
FD treatment and provide an integrative therapy that targets multiple 
pathophysiological mechanisms implicated in FD.  
 
4.0 
Study Endpoints* 
4.1 Describe the primary and secondary study endpoints. 
Primary Endpoint: (1) Assessment of usability will be performed at 
the second visit by collecting the subject's feedback using a 
structured questionnaire, as recommended by the IEC 60601-1-6 
(Usability Standard). Each subject will grade multiple questions 
using a 0-to-5 scale to assess the usability, design effectiveness, 
satisfaction, and comfort of the device functionalities. (2) 
Assessment of safety includes a listing of the types, rates, and 
severity of AutoSTEA-related adverse events, including skin 
irritation, infection, or pain in the stimulation region. 
Secondary Endpoint: (1) Functional Dyspepsia Symptom Diary 
(FDSD), an eight-item daily symptom diary, is developed according 
to recommendations in the FDA Patient-Report-Outcome Guidance 
to assess severity of FD symptoms. Each item is scored on an 11-
point numeric rating scale from 0 (no symptoms) to 10 (worst 
imaginable symptoms). (2) Disease-Specific Quality of Life will be 
assessed by the short version of the Nepean Dyspepsia Index (NDI), 
scored from 0 to 100, with higher scores indicating a worse quality 
of life. 
4.2 Describe any primary or secondary safety endpoints. 
• Primary Safety Endpoint: The primary safety endpoint involves a 
comprehensive evaluation of AutoSTEA-related adverse events. 
This will encompass recording the incidence, type, and severity of 
any adverse effects directly associated with the use of AutoSTEA 
therapy. Specific adverse events of interest include, but are not 
limited to, skin irritation, infection, and pain within the area of 
stimulation. The severity of these events will be classified using 
standard grading scales, and their relationship to the AutoSTEA 
device will be thoroughly assessed to ensure accurate attribution. 
• Secondary Safety Endpoint: As a non-significant risk device, 
AutoSTEA is anticipated to be well-tolerated by participants. 
However, secondary safety endpoints will include monitoring for 

 
 
 
 
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any unexpected adverse events or reactions throughout the study 
duration. This includes evaluating the long-term impact of treatment 
on functional dyspepsia symptoms, if applicable, and any other 
unintended outcomes related to the device's use. These assessments 
will be conducted through follow-up interviews and examinations, 
ensuring comprehensive safety monitoring beyond immediate 
treatment effects. 
5.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
According to the FDA 《Information Sheet Guidance For IRBs, Clinical 
Investigators, and Sponsors: Significant Risk and Nonsignificant Risk 
Medical Device Studies》, Functional Non-Invasive Electrical 
Neuromuscular Stimulators and Transcutaneous Electric Nerve Stimulation 
(TENS) Devices, excluding those used for chest pain/angina, are typically 
classified as non-significant risk devices (Appendix A, page 9). The 
AutoSTEA, which offers TEA automatically synchronized with the user’s 
respiratory patterns, fits within this non-significant risk classification. 
Tailored for the management of Functional Dyspepsia (FD), the AutoSTEA 
mirrors the safety and functional attributes of conventional TENS devices, 
incorporating non-implantable features, low-power electrical stimulation, 
and an innovative automatic respiratory synchronization to improve user 
experience and comfort in treating FD, a condition that is not life-
threatening. This safety and functionality equivalence is further supported 
by studies involving traditional TEA devices, which do not feature 
automatic respiratory synchronization. 
The AutoSTEA device is engineered to automatically synchronize electrical 
stimulation with users’ respiratory paces, providing non-invasive, low-
power electrical stimulation to the skin. The device comprises a 
microstimulator with a controller, a chest strip, and standard TENS 
electrodes, tailored for FD patients. The AutoSTEA device is designed to be 
user-friendly, allowing patients to self-administer therapy. 
How the device functions: A prototype was made as shown in Fig. 1. The 
chest strip is a non-invasive and wearable strip which is made with a Velcro 
strip embedded with a sensor to track the user’s respiratory paces. The user 
wears the strip, and strategically places the reusable and disposable 
electrodes on the target sites, including either ST36 (leg shank) or PC6 
acupoints (wrists), or both. The user will sit in a comfortable chair and turn 
on the stimulator. The AutoSTEA will track the user’s breathing paces, and 
automatically deliver stimulation at each start of inhalation for 2 seconds in 
each respiratory cycle. The stimulation duration will be set following the 

 
 
 
 
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clinical trial protocol. A video is attached to show how the device is set 
for use.  
The microstimulator: The latest prototype of microstimulator controller 
measures 4.7 inch x 4 inch x 1.2 inch and weighs 228 grams, offering 
enhanced portability (Fig 2), The prototype has two AA batteries to provide 
the power (total 3 Volts), and a power management system is established to 
maintain a sustainable, efficient and safe use of the power. 
Electrical stimulation parameters: (1) The device allows the user to adjust 
the stimulation intensity up to 10 mA current through the adjustment knob. 
This meets the standard requirements for current commercial TENS devices. 
Any changes during stimulation will be logged in the stimulator memory 
card, and the log can be retrieved by the doctor for reviewing. (2) The 
generated electrical waveforms could be in the type of square or sine. This 
will be set by the medical professionals and recorded for future review and 
analysis.  (3) The frequency of the waveforms can be set in the range of 1 
Hz-200 Hz. And this will also be set by the medical professionals and 
recorded for review and analysis. 
Design and manufacturing the microstimulator: (1) The cover of the 
latest prototype was designed in CAD software, and then additively 
manufactured (3d printing). The material of the cover is ABS (acrylonitrile 
butadiene styrene) which is the most common filament used in 3D printing. 
(2) The microcontroller and electronic components (e.g. resistors and 
capacitors) are built on a solderable printed circuit board (PCB). All these 
components can be operated or functional in the temperature range of -40 °C 
~ 120 °C. Flexible AWG stranded electrical wires which could be operated 
in the temperature range of -60 °C ~ 120 °C, are used for the connection 
among different electronic components. (3) The PCB, battery case and 
relevant adapters are installed in the cover box, which is designed with 
engineering stands. The components are fixed on the stands with metal 
screws. Some parts are also further secured with silicon glue. All the 
components are fixed steadily to increase reliability. 
Chest strip for respiration tracking: The chest strip is for tracking real-
time respiration. The chest strip is embedded with a strain-gauge force 
sensor. The sensor is connected with the end of a power cord that has a male 
plug Jack on the other end. The sensor is a type of thin film and flex/bend 
pressure sensor that is commercially tailored for breathing sensing. The 
Velcro attachment method is for home use as the user can easily adjust the 
tightness on their own preference. The algorithm programmed in the 

 
 
 
 
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simulator microcontroller can guarantee the precision of the breathing 
tracking and avoid the influence from the tightness of installment. 
Strip and sensor parameters: (1) The strip was made of double layer 
nylon web with 1-1/2 inch in width, 48 inch in length and 0.37 inch in 
thickness. If necessary, the strip size will be modified to accommodate for a 
wide population. The feature of Velcro is around the strip. (2) The thin film 
and flex pressure sensor is 23.6 inch in length, 0.6 inch in width and 0.35 
mm in thickness. It can be operated in the temperature range of -20 °C ~ 60 
°C. (3) The thin film and flex/bend pressure sensor works with a 3-volt 
power source. (4) The power cord is used to transmit the sensed electrical 
signal, and it has a standard 90-degree right angle male plug Jack. 
Design and assembling the chest strip: (1) The thin film and flex/bend 
pressure sensor is soldered on one of the ends of the power cord and taped 
by adhesive electrical tape. (2) High adhesive electrical tape is used to fix 
the flex bend sensor around the strip. (3) Thin and adhesive athletic tape was 
wrapped around the strip to cover the sensor. 
Upgraded Microstimulator for the proposed Phase I Feasibility Trial: 
For the proposed Phase I feasibility trial, we will employ an enhanced 
version of our microstimulator that retains its core functionality and 
stimulation parameters (refer to Fig. 4). This advanced model introduces 
several key improvements to optimize performance and user experience: (1) 
Two stimulation channels will be created so that the microstimulator can 
stimulate two sites simultaneously. (2) The microstimulator will be 
upgraded to a pager size from the protocol, with a physical dimension of 
approximately 4 inch x 3 inch x 1.2 inch. All the circuits and relevant 
electrical components will be designed in a thin PCB to achieve the 
dimensions. (3) A tiny display will be added so that in the stimulation mode, 
a count-down timer will be displayed to show the remaining stimulation 
time. (4) The microstimulator will be upgraded to be powered by a 3V 
rechargeable battery. The rechargeable battery will have an overcharge and 
over-discharge protection to prevent it from overheating or explosion. (5). 
Another layer of nylon cloth will be used to cover the sensing area of the 
chest strip. 
These design considerations and forthcoming improvements underscore our 
commitment to delivering a safe, effective, and user-centered therapy 
solution for FD, with the AutoSTEA poised to set new standards in non-
invasive neuromuscular stimulation for gastrointestinal disorders. 
 

 
 
 
 
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Figure 4: An upgraded micro-stimulator that maintains current functions and 
stimulation parameters for the proposed feasibility trial 
 
5.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
• Storage and Security of the AutoSTEA Device: The AutoSTEA 
devices will be securely stored in a locked cabinet within the 
Principal Investigator’s (PI) office (S1-105B, Humann building), 
which is located in a restricted access area to ensure that access is 
limited to authorized study personnel only. The office is equipped 
with security measures including keycard access and surveillance 
cameras to prevent unauthorized entry and ensure the devices' 
safety and integrity. 
• Handling and Administration: Only trained and authorized 
investigators will handle and administer the AutoSTEA devices to 
ensure proper use in accordance with the study protocol. Training 
sessions will be conducted prior to the commencement of the study 
to familiarize all authorized personnel with the device's operational 
procedures, safety features, and emergency protocols. The training 
will include instructions on how to correctly set up the device, 
adjust settings according to the study protocol, monitor participants 
during use, and respond to any device-related adverse events. 
• Documentation and Accountability: A logbook will be 
maintained in the PI’s office to record the checkout and return of 
each AutoSTEA device by the study personnel. The log will include 
the date, time, device serial number, and the name of the 
investigator using the device to ensure thorough tracking of device 
utilization and accountability. This logbook will be regularly 
reviewed by the PI to monitor compliance with the study protocol 
and handling procedures. 
• Disposal and Decontamination: Decontamination and Reuse: 
Upon completion of the study or in the event of device malfunction, 
the AutoSTEA devices will be thoroughly decontaminated 

 
 
 
 
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according to established safety protocols. This process ensures the 
devices are safe for reuse, protecting both environmental safety and 
participant confidentiality. Devices will be evaluated for 
functionality and safety in accordance with the manufacturer's 
guidelines and applicable regulatory requirements. Only devices 
that meet these stringent standards will be reactivated for future use. 
Should a device not meet the necessary criteria for reuse, it will be 
safely deactivated and disposed of according to manufacturer 
guidelines and regulatory standards. 
5.2 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 
 
Regulatory Sponsor and Compliance: Athena Digital Health LLC 
is the designated holder of the IDE for the AutoSTEA device. 
Although our IRB has preliminarily defined the proposed AutoSTEA 
device as non-significant risk device for the proposed study. This 
week, Athena Digital Health LLC has undertaken the submission of 
a Q-Submission to the FDA, aimed at obtaining a Study Risk 
Determination. This crucial step is intended to clarify the 
classification of the upcoming Phase I feasibility clinical study of the 
AutoSTEA device — specifically, whether it will be categorized as 
significant risk, non-significant risk, or exempt from the regulatory 
requirements stipulated under IDE regulations, in accordance with 
21 CFR part 812. This determination is essential for ensuring 
compliance with FDA regulations and guiding the study’s oversight 
protocols. 
 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
 

 
 
 
 
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6.0 
Procedures Involved* 
6.1 Describe and explain the study design. 
Forty patients with functional dyspepsia (FD) will be enrolled in a 
two-week, single-arm trial to evaluate the safety and usability of the 
AutoSTEA treatment. Aligning with the NIH's directives to ensure a 
diverse participant pool, our recruitment strategy is designed to 
include a minimum of 15 overweight or obese patients with FD, 
characterized by a Body Mass Index (BMI) of 25-40. Additionally, 
we are committed to achieving gender balance within the study, 
targeting the inclusion of at least 15 female participants. This 
approach underscores our dedication to assessing the AutoSTEA 
treatment's feasibility across a broad spectrum of FD patients, with 
particular focus on those who are overweight/obese and female. 
AutoSTEA will be applied at acupuncture points ST36 and PC6 
(Figs. 5&6).  
 
 
 
 
 
 
6.2 Provide a description of all research procedures being performed 
and when they are performed, including procedures being performed 
to monitor subjects for safety or minimize risks. 
This study involves a series of structured procedures to ensure the 
comprehensive evaluation of the AutoSTEA treatment's safety and 
usability for patients with FD. Participants are scheduled for two 
hospital visits, marking the beginning and conclusion of the study 
period. 
During the initial visit, participants will undergo a detailed training 
session. This session is designed to cover the completion of study-
related questionnaires and the operation of the AutoSTEA device, 
including the utilization of an associated smartphone application for 
daily symptom tracking. To facilitate ease of use and address any 
potential issues during the study, this training will be recorded, 
providing participants with a reference. Furthermore, on-demand 
phone support will be readily available to assist with any inquiries or 
difficulties encountered during home use of the device. 
 
Figure 6. Device 
locations for PC6 
AutoSTEA (red 
dot). 
 
 
Figure 5. Device 
locations for ST36 
AutoSTEA (red 
dot). 
 

 
 
 
 
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Data collection and monitoring constitute a critical component of 
this study. Primary and secondary outcome measures will be 
systematically collected during hospital visits and supplemented by 
phone check-ins during the first week of the study. These efforts are 
aimed at closely monitoring participant safety and collecting 
valuable data on symptom progression. Furthermore, it is important 
to clarify that the option to complete questionnaires electronically is 
an additional, voluntary method available to participants. During 
their initial visit, all participants will be informed about and 
consented to this option. Those who opt-in will receive an invitation 
to complete the questionnaires via a secure REDCap link, delivered 
through their preferred method of communication, either email 
and/or SMS text message. This flexibility in questionnaire 
completion is designed to enhance participant convenience and 
accessibility, while rigorously maintaining the integrity and 
confidentiality of their responses. Additionally, the AutoSTEA 
device is equipped to automatically record therapy parameters as 
well as daily usage data, which will be stored in the device's 
memory. This information will subsequently be downloaded for 
comprehensive analysis to assess patients’ adherence to the 
treatment protocol. 
To ensure the safety of participants and minimize potential risks 
associated with device use, several precautionary measures will be 
implemented. Prior to electrode application, the skin contact area of 
the AutoSTEA device will be meticulously cleaned with skin prep 
jelly to reduce electrode-skin impedance, a crucial step for 
maintaining participant comfort and device efficacy. Moreover, the 
stimulation parameters for the AutoSTEA therapy have been 
carefully selected based on robust evidence of their safety and 
effectiveness in managing symptoms of FD. 
In addition to the primary research procedures outlined, our study 
will incorporate the collection of historical data on the management 
of functional dyspepsia (FD) with traditional medical treatments, 
including antacids, proton pump inhibitors (PPIs), H2 blockers, and 
tricyclic antidepressants (TCAs), during routine clinical care. This 
will involve gathering demographic details, symptomatology, and 
treatment responses as documented in patient records. To safeguard 
patient privacy, all data will be de-identified and handled in 
accordance with HIPAA regulations and IRB-approved protocols. 
The integration of this historical data aims to deepen our 
understanding of the comparative effectiveness and outcomes of the 
AutoSTEA treatment relative to standard care, enhancing our 
analysis and enabling more informed conclusions about the 
AutoSTEA device's role in the FD treatment paradigm. This 

 
 
 
 
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comprehensive approach not only adheres to ethical standards but 
also contributes to the robustness of our research findings. 
6.3 Describe: 
• 
Procedures performed to lessen the probability or magnitude 
of risks. 
o To minimize the probability and severity of risks 
associated with this study, we have implemented a 
rigorous participant selection process. This process 
involves excluding individuals with pre-existing 
conditions that could elevate risk levels or interfere 
with study outcomes. The AutoSTEA device, 
identified as a non-significant risk investigational 
device by preliminary assessments, is central to our 
research. It is designed for the dual purposes of 
evaluating usability and ensuring safety within a 
meticulously controlled environment. Continuous 
and thorough monitoring of all participants for any 
adverse events related to the device will be 
conducted to promptly address and mitigate 
potential risks.. 
• 
All drugs and devices used in the research and the purpose of 
their use, and their regulatory approval status. 
o The AutoSTEA device, which operates on 
principles similar to those of a Transcutaneous 
Electrical Nerve Stimulation (TENS) unit, is 
classified as a non-significant risk device. This 
classification is based on its intended use and the 
preliminary risk assessment submitted to the FDA. 
In this study, the AutoSTEA device's primary 
function is to assess its usability and safety among 
participants with functional dyspepsia, under 
controlled conditions. Continuous monitoring for 
any adverse events will be rigorously maintained to 
ensure participant safety and compliance with 
regulatory standards. 
• 
The source records that will be used to collect data about 
subjects. (Attach all surveys, scripts, and data collection 
forms.) 
o Data will be collected from structured 
questionnaires, symptom diaries, and quality of life 
indices. These instruments have been chosen for 
their relevance to the study's objectives and their 
established validity in similar research contexts. 

 
 
 
 
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6.4 What data will be collected during the study and how that data will 
be obtained. 
• Data collected will include usability feedback, adverse event 
reports, FD symptom diaries, and quality of life assessments. These 
will be obtained through direct input from participants into the 
provided questionnaires and diaries, as well as through objective 
measurements recorded during hospital visits. Furthermore, it is 
important to clarify that the option to complete questionnaires 
electronically is an additional, voluntary method available to 
participants. During their initial visit, all participants will be 
informed about and consented to this option. Those who opt-in will 
receive an invitation to complete the questionnaires via a secure 
REDCap link, delivered through their preferred method of 
communication, either email and/or SMS text message.  
6.5 If there are plans for long-term follow-up (once all research related 
procedures are complete), what data will be collected during this 
period.  
• While no long-term follow-up is planned post-study, any significant 
findings related to safety during the trial will be reported to the IRB 
and participants will be provided with appropriate care 
recommendations. 
6.6 For Humanitarian Use Device (HUD) uses provide a description of 
the device, a summary of how you propose to use the device, 
including a description of any screening procedures, the HUD 
procedure, and any patient follow-up visits, tests or procedures. 
• This section is not applicable as the AutoSTEA device is not being 
considered for HUD use in this study. It is being evaluated under a 
Q-Submission to the FDA to determine its risk classification and is 
not yet approved or exempted under IDE regulations. 
7.0 
Data and Specimen Banking* 
7.1 If data or specimens will be banked for future use, describe where 
the specimens will be stored, how long they will be stored, how the 
specimens will be accessed, and who will have access to the 
specimens. 
• As this study does not involve the collection of biological 
specimens, there will be no specimen banking. However, data 
generated from the study will be securely stored in a HIPAA-
compliant cloud data server, encrypted and password-protected. 
Access to this data will be restricted to authorized study personnel 
only, with rigorous controls in place to ensure confidentiality and 
integrity. 

 
 
 
 
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7.2 List the data to be stored or associated with each specimen. 
• The data to be stored will include de-identified participant 
information, device usability and safety data, FD symptom data, 
and device parameter data in the device memory. This approach 
ensures participant privacy while facilitating future research and 
analysis. 
7.3 Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who 
can obtain data or specimens, and the data to be provided with 
specimens. 
• Given the absence of specimen banking and the strict privacy 
protections in place, requests for data release will be handled on a 
case-by-case basis, requiring approval from the principal 
investigator. Release will be contingent upon the scientific merit of 
the request and compliance with all applicable privacy laws and 
regulations. Data released for approved requests will include only 
de-identified information to protect participant confidentiality. 
8.0 
Sharing of Results with Subjects* 
8.1 Describe whether results (study results or individual subject results, 
such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) will be shared with subjects or others (e.g., the 
subject’s primary care physicians) and if so, describe how the results 
will be shared. 
• Results are not going to be shared 
9.0 
Study Timelines* 
9.1 Describe: 
• 
The duration of an individual subject’s participation in the 
study. 
o A 2-week duration. 
• 
The duration anticipated to enroll all study subjects. 
o 12 months 
• 
The estimated date for the investigators to complete this study 
(complete primary analyses) 
o 02/26/2027 
10.0 Inclusion and Exclusion Criteria* 
10.1 Describe how individuals will be screened for eligibility. 
Adult patients exhibiting symptoms of functional dyspepsia, who 
either have normal esophagogastroduodenoscopy (EGD) results or 

 
 
 
 
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EGDs indicating mild gastric or duodenal inflammation that does 
not account for their dyspeptic symptoms, will be considered for 
screening. 
10.2 Describe the criteria that define who will be included or excluded in 
your final study sample. 
• Inclusion criteria: We will recruit men and women aged 18 years 
and older who meet the Rome IV criteria for functional dyspepsia. 
Participants must be willing and able to attend the two-week trial, 
understand the study procedures, complete questionnaires, and 
provide informed consent.  
• Exclusion criteria: Patients with dyspeptic symptoms fully resolved 
by antisecretory, antidepressants, or prokinetics therapy will be 
excluded. However, those on a stable dose of PPIs, antidepressants, 
or prokinetics who experience only partial symptom resolution may 
be included.  We will not enroll individuals with a history of active 
use of NSAIDs, unhealed esophagitis, unhealed ulcer disease, or 
other organic upper gastrointestinal diseases that explain dyspepsia, 
nor those with a history of upper GI surgeries, GI cancers, 
uncontrolled diabetes (types 1 or 2), severe psychiatric conditions, 
uncontrolled medical disorders, total knee replacement, or above-
the-knee amputation. Additionally, individuals with positive H. 
pylori infection without confirmed eradication are excluded.   
10.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the 
above populations as subjects in your research unless you indicate 
this in your inclusion criteria.) 
• 
Adults unable to consent- will be excluded 
• 
Individuals who are not yet adults (infants, children, 
teenagers)- will be excluded 
• 
Pregnant women- will be excluded 
• 
Prisoners- will be excluded 
11.0 Vulnerable Populations* 
11.1 If the research involves individuals who are vulnerable to coercion 
or undue influence, describe additional safeguards included to 
protect their rights and welfare. 
• 
Not indicated. Vulnerable populations will not be included in 
the study. 
12.0 Local Number of Subjects 
12.1 Indicate the total number of subjects to be accrued locally. 

 
 
 
 
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• The primary source for recruitment for this study will be the 
MetroHealth outpatient clinic. About 1,000 FD patients are seen 
annually at the MetroHealth outpatient clinic. 
12.2 If applicable, distinguish between the number of subjects who are 
expected to be enrolled and screened, and the number of subjects 
needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
• We plan to recruit 40 subjects who meet the eligibility criteria to 
ensure that 30 participants will complete the study, conservatively 
assuming a 25% attrition. 
13.0 Recruitment Methods 
13.1 Describe when, where, and how potential subjects will be recruited. 
Recruitment will occur at the MetroHealth outpatient clinic, 
targeting patients with FD. Gastroenterology specialists will identify 
eligible patients during clinic visits, supplemented by study flyers 
and social media outreach.  
13.2 Describe the source of subjects. 
Subjects will be sourced from the outpatient GI clinic patient 
population, specifically those diagnosed with FD. 
13.3 Describe the methods that will be used to identify potential subjects. 
Potential subjects will be identified by clinic gastroenterologists 
based on eligibility criteria, with the study coordinator facilitating 
further screening and enrollment processes. 
13.4 Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For advertisements, 
attach the final copy of printed advertisements. When advertisements 
are taped for broadcast, attach the final audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Recruitment materials include flyers posted in clinics and IRB-
approved ads on social media platforms, offering study information 
and coordinator contact details. 
13.5 Describe the amount and timing of any payments to subjects. 
There will not be any sort of payment or financial compensation for 
participants. Due to the study not being funded by the NIH or other 
external source, payments will not be available at any stage.   
14.0 Withdrawal of Subjects* 

 
 
 
 
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14.1 Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
Subjects may be withdrawn involuntarily under circumstances like 
non-compliance with study procedures or if continuing poses a 
health risk.  
14.2 Describe any procedures for orderly termination. 
An orderly termination process will involve a final assessment and 
discussion of the withdrawal’s implications for the study’s outcomes. 
14.3 Describe procedures that will be followed when subjects withdraw 
from the research, including partial withdrawal from procedures 
with continued data collection. 
Upon withdrawal, subjects may choose to discontinue all study 
activities or permit ongoing data collection from completed 
procedures. The team will respect participant decisions, ensuring a 
clear communication path for any concerns or withdrawal requests. 
15.0 Risks to Subjects* 
15.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in 
the research. Include as may be useful for the IRB’s consideration, a 
description of the probability, magnitude, duration, and reversibility 
of the risks. Consider physical, psychological, social, legal, and 
economic risks. 
The primary foreseeable risk to participants involves potential 
allergic reactions to the adhesives used in ECG electrodes. While 
such reactions are generally mild and localized, involving symptoms 
like skin irritation or rash, they are considered low in probability and 
magnitude. The discomfort is typically short-lived and reversible 
upon removal of the electrodes. No significant physical, 
psychological, social, legal, or economic risks are anticipated from 
participating in this study. 
15.2 If applicable, indicate which procedures may have risks to the 
subjects that are currently unforeseeable. 
Currently, no procedures are anticipated to pose unforeseeable risks 
to the subjects. 
15.3 If applicable, indicate which procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
This study will not include pregnant women, thus eliminating the 
risk to embryos or fetuses. 
15.4 If applicable, describe risks to others who are not subjects. 

 
 
 
 
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There are no expected risks to individuals who are not subjects of the 
study. 
16.0 Potential Benefits to Subjects* 
16.1 Describe the potential benefits that individual subjects may 
experience from taking part in the research. Include as may be 
useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. 
Individual subjects participating in this research may experience 
improvements in their symptoms of FD, leading to enhanced quality 
of life. While the primary aim of the study is to evaluate the safety 
and usability of the AutoSTEA treatment, symptom relief as a result 
of the therapy could offer significant personal benefits to 
participants. The probability and magnitude of these benefits, 
although optimistic, will vary among subjects, and any 
improvements in symptoms are anticipated to persist for the duration 
of the study and potentially beyond, depending on individual 
responses to the treatment. 
16.2 Indicate if there is no direct benefit. Do not include benefits to 
society or others. 
This study is designed to provide direct benefits to participants 
through potential symptom relief and improved quality of life. 
17.0 Data Management* and Confidentiality 
17.1 Describe the data analysis plan, including any statistical procedures 
or power analysis. 
Descriptive statistics will be calculated for all variables, with 
appropriate tests applied based on data distribution. Continuous 
variables will undergo the Kolmogorov-Smirnov test to confirm 
normality, followed by the paired t-test or the Wilcoxon rank-sum 
test as applicable. Categorical variables will be analyzed using 
Pearson’s χ2 test. 
17.2 Describe the steps that will be taken to secure the data (e.g., 
training, authorization of access, password protection, encryption, 
physical controls, certificates of confidentiality, and separation of 
identifiers and data) during storage, use, and transmission. 
Data will be securely stored RedCAP, accessible only by the PI and 
research assistant, ensuring compliance with FDA 21 CFR Part 11 
through password protection and encryption.  
17.3 Describe any procedures that will be used for quality control of 
collected data. 

 
 
 
 
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Data collection accuracy will be ensured by providing participants 
with questionnaire instructions and by having trained personnel 
collect stimulation/parameter data in the memory card of the 
AutoSTEA device.   
17.4 Describe how data or specimens will be handled study-wide: 
• 
What information will be included in that data or associated 
with the specimens? 
Data, including questionnaire and device stimulation/parameter 
information, will be stored in RedCAP. The data will be 
retained for up to five years post-study, with access limited to 
the PI and research assistants. The research assistant will 
manage data receipt and transmission. 
• 
Where and how data or specimens will be stored? 
 
Stored in secured MHS network drive in RedCAP, accessible 
only by the PI and IRB approved members of the study team, 
ensuring compliance with FDA 21 CFR Part 11 through 
password protection and encryption. 
• 
How long the data or specimens will be stored? 
o Up to 5 years after the research concluded 
• 
Who will have access to the data or specimens? 
o PI and research assistants  
• 
Who is responsible for receipt or transmission of the data or 
specimens? 
o Research assistant 
• 
How data or specimens will be transported? 
For this study, data and specimens will not require physical 
transportation as there are no tangible specimens collected, and 
all data will be digitally managed and stored. Any transfer of 
digital data will be conducted securely via encrypted electronic 
means, ensuring compliance with confidentiality and data 
protection standards. This approach eliminates risks associated 
with physical transport and aligns with modern data 
management practices in clinical research. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
This section is required when research involves more than Minimal Risk 
to subjects. 
N/A, as this is a non-significant risk study. 

 
 
 
 
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19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place 
limits on whom they interact or whom they provide personal 
information. 
To protect the privacy interests of participants, confidentiality will 
be rigorously maintained by all investigators, staff, sponsors, and 
their agents. This includes clinical information related to study 
participants. Strict confidentiality will be ensured for the study 
protocol, documentation, data, and all generated information. Any 
shared data or records will be de-identified, removing all Protected 
Health Information (PHI) and replaced with a unique study 
identifier. Information will only be released with participant consent 
or for regulatory oversight by entities such as the IRB, FDA, OHRP, 
or safety committees, to ensure study safety, monitor side effects, 
and facilitate outcome analysis. 
19.2 Describe what steps you will take to make the subjects feel at ease 
with the research situation in terms of the questions being asked and 
the procedures being performed. “At ease” does not refer to 
physical discomfort, but the sense of intrusiveness a subject might 
experience in response to questions, examinations, and procedures. 
To ensure participants feel comfortable and respected throughout the 
research process, we will adopt a sensitive and respectful approach 
when asking questions and performing procedures. This involves 
framing questions in a non-judgmental manner and explicitly 
seeking consent before any examinations or procedures are 
conducted. Additionally, we will provide clear explanations about 
the purpose and nature of each question and procedure, allowing 
participants to feel informed and in control of their participation. 
This respectful engagement aims to minimize any sense of 
intrusiveness and foster a trusting environment. 
19.3 Indicate how the research team is permitted to access any sources of 
information about the subjects. 
Access to subject information will be strictly regulated within the 
research team. The study coordinator, tasked with data collection and 
management, will utilize Case Report Forms (CRFs) for 
documenting participant visits and ensuring data completeness. 
These CRFs will undergo a review process for completeness by the 
study coordinator before confirmation. Additionally, to maintain 
rigorous oversight, the primary investigator or co-investigators will 
conduct bi-annual reviews of the CRFs. This structured approach 
ensures that only designated research personnel have access to 

 
 
 
 
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participant information, safeguarding privacy and maintaining data 
integrity.  
20.0 Compensation for Research-Related Injury 
20.1 If the research involves more than Minimal Risk to subjects, describe 
the available compensation in the event of research related injury. 
• The research involved minimal risk to subjects 
20.2 Provide a copy of contract language, if any, relevant to 
compensation for research-related injury. 
• N/A 
21.0 Economic Burden to Subjects 
21.1 Describe any costs that subjects may be responsible for because of 
participation in the research. 
Participants may incur some costs due to their involvement in the 
research, primarily related to travel to the clinic and parking fees. 
These are the anticipated direct out-of-pocket expenses for subjects.  
22.0 Consent Process 
22.1 Indicate whether you will you be obtaining consent, and if so 
describe: 
• 
Where will the consent process take place 
The consent process will be conducted in a flexible and 
accessible manner. Identified subjects will be approached by 
the PI or designated research investigators either in the clinic 
setting or via telephone, ensuring convenience and 
consideration for the participant's preferences and 
circumstances. This approach facilitates a thorough and 
personalized consent discussion, allowing for any questions or 
concerns to be addressed promptly and effectively. 
• 
Any waiting period available between informing the 
prospective subject and obtaining the consent. 
While no specific waiting period is mentioned, it's critical to 
ensure that participants have enough time to consider their 
participation fully. If a waiting period isn't mandated, ensuring 
participants understand they can take the time they need before 
consenting is important. 
• 
Any process to ensure ongoing consent. 

 
 
 
 
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Highlighting that participants may withdraw at any time 
emphasizes respect for autonomy and ongoing consent, a 
cornerstone of ethical research.  
• 
Whether you will be following the IRB’s SOPs for the consent 
process (Chapter 12, Section d). If not, describe: 
Confirming adherence to the IRB’s Standard Operating 
Procedures for the consent process reassures that the study will 
follow established ethical guidelines, ensuring participant 
rights and welfare are prioritized throughout the study 
Non-English Speaking Subjects 
• 
Not indicated 
Waiver or Alteration of Consent Process and Waiver or Alteration 
of HIPAA Authorization (consent and HIPAA Authorization will 
not be obtained, required information will not be disclosed, or the 
research involves deception)  
• 
Not indicated 
Subjects who are not yet adults (infants, children, teenagers) 
• 
Not indicated 
Cognitively Impaired Adults 
• 
Not indicated 
Adults Unable to Consent 
• 
Not indicated 
23.0 Process to Document Consent in Writing 
23.1 Describe whether you will be following the IRB’s SOPs on written 
documentation of consent (Chapter 12, Section e). If not, describe 
whether and how consent of the subject will be documented in 
writing. 
Informed consent is a process that is initiated prior to the 
individual’s agreeing to participate in the study and continues 
throughout the individual’s study participation.  Extensive discussion 
of risks and possible benefits of this therapy will be provided to the 

 
 
 
 
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study participants and their families. Consent forms (written in non-
technical language) describing in detail the study 
interventions/products, study procedures, and risks are given to the 
study participant and written documentation of informed consent is 
required prior to starting intervention/administering study product.  
Consent forms will be IRB-approved and the study participant will 
be asked to read and review the document.  Upon reviewing the 
document, the study team member will explain the research study to 
the study participant and answer any questions that may arise.  The 
study participant will sign the informed consent document prior to 
any procedures being done specifically for the study.  The study 
participants should have the opportunity to discuss the study with 
their surrogates or think about it prior to agreeing to participate.  The 
study participants may withdraw consent at any time throughout the 
course of the trial.  A copy of the informed consent document will be 
given to the study participants for their records.  The rights and 
welfare of the study participants will be protected by emphasizing to 
them that the quality of their medical care will not be adversely 
affected if they decline to participate in this study. 
24.0 Setting 
24.1 Describe the sites or locations where your research team will 
conduct the research. 
• 
Identify where your research team will identify and recruit 
potential subjects. 
The primary source for recruitment for this study will be the 
MetroHealth outpatient clinic. About 1,000 FD patients are 
seen annually at the MetroHealth.  
• 
Identify where research procedures will be performed. 
The research procedures will be performed in the outpatient 
clinic or GI function unit. 
• 
Describe the composition and involvement of any community 
advisory board. 
o N/A 
• 
For research conducted outside of the organization and its 
affiliates describe:  
o N/A 
25.0 Resources Available 

 
 
 
 
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25.1 Describe the resources available to conduct the research: For 
example, as appropriate: 
• 
Justify the feasibility of recruiting the required number of 
suitable subjects within the agreed recruitment period. For 
example, how many potential subjects do you have access to? 
What percentage of those potential subjects do you need to 
recruit? 
 
Given that approximately 1,000 FD patients are seen annually 
at the MetroHealth outpatient clinic, the recruitment goal 
appears feasible. Assuming a conservative interest and 
eligibility rate, even a small percentage of this patient pool 
would be sufficient to meet the study's recruitment targets 
within the specified period. This approach, anchored in an 
existing, high-volume clinical setting, provides a solid 
foundation for achieving the required sample size, ensuring the 
study's feasibility and success. 
 
• 
Describe the time that you will devote to conducting and 
completing the research. 
o Dr. Kurin and his research team, including clinical 
coordinator will have designated time of the week 
to perform the study. 
• 
Describe your facilities. 
o Outpatient clinic or GI function unit will be used to 
perform the study.  
• 
Describe the availability of medical or psychological resources 
that subjects might need as a result of an anticipated 
consequences of the human research. 
o Dr. Kurin and research assistant will be available 
to provide medical advice if needed. 
• 
Describe your process to ensure that all persons assisting with 
the research are adequately informed about the protocol, the 
research procedures, and their duties and functions. 
 
To ensure all research personnel are thoroughly familiar with 
the study protocol, procedures, and their specific roles, we will 
conduct regular team meetings. During these sessions, 
responsibilities will be clearly outlined and assigned, ensuring 
each team member understands their duties and the importance 
of adherence to the study protocol. This structured approach 
promotes a cohesive and informed research environment, 
essential for maintaining the study's integrity and ethical 
standards. 

 
 
 
 
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26.0 Multi-Site Research* 
The research will be conducted across two sites, including the 
MetroHealth Main Campus and the Parma Campus. This two-site 
approach will enable us to access a broader participant base, enhancing the 
study's diversity and statistical power.