Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
Phase: NA
Conditions: Carpal Tunnel Syndrome, CTS, Carpal Tunnel
Sponsor: Sonex Health, Inc.

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No. 90079-TP, Rev.05 
Trial of Ultrasound guided carpal tunnel release versus 
Traditional Open Release 
(TUTOR) 
 
 
 
CLINICAL STUDY PROTOCOL: 
No. 90079-TP Revision 05 
Dated November 18, 2022 
 
 
SPONSOR: 
Sonex Health, Inc. 
950 Blue Gentian Road, Suite 200 
Eagan, MN 55121 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This study will be conducted in compliance with the protocol and applicable regulatory requirements. 
 
Confidential Information 
No use or disclosure of this document outside The Institute of Advanced Ultrasound Guided Procedures 
(The Institute) is permitted without prior written authorization from The Institute. 
 

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No. 90079-TP, Rev.05 
 
Trial of Ultrasound guided carpal tunnel release versus 
Traditional Open Release 
(TUTOR) 
 
Protocol Signature Page 
 
No. 90079-TP Revision 05 
Dated November 18, 2022 
 
 
 
 
I have read this protocol and agree to adhere to the requirements.  I will provide copies of this 
protocol and all pertinent information to the study personnel under me.  I will discuss the material 
with them and ensure they are fully informed regarding the conduct of the study according to this 
protocol, applicable regulatory requirements, and IRB requirements. 
 
I agree to and understand the material presented in this protocol and must not publicly disclose in 
any manner the design, results, or conclusions of this investigation without prior written consent of 
Sonex Health. 
 
 
 
 
__________________________ _________ 
Clinical Site Name 
 
 
 
___________________________________ 
 
 
_____________________ 
Site Principal Investigator  
 
 
 
 
Date 
Signature 
 
 
 
 
 
 
__________________________ ________ 
Site Principal Investigator  
Printed Name 

 
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No. 90079-TP, Rev.05 
TABLE OF CONTENTS 
 
1. PROTOCOL SYNOPSIS .......................................................................... 5 
2. LIST OF ABBREVIATIONS ................................................................... 7 
3. BACKGROUND AND OBJECTIVE ...................................................... 8 
4. DEVICE DESCRIPTION ......................................................................... 9 
5. SUMMARY OF PRIOR CLINICAL EXPERIENCE .........................10 
6. STUDY PROCEDURES .........................................................................13 
6.1 
Investigational Site Selection ........................................................................... 13 
6.2 
Subject Selection ............................................................................................... 13 
6.2.1 
Inclusion Criteria ........................................................................................ 13 
6.2.2 
Exclusion Criteria ....................................................................................... 13 
6.2.3 
Screen Failures ........................................................................................... 14 
6.2.4 
Timing of Patient Screening........................................................................ 14 
6.3 
Randomization .................................................................................................. 14 
6.4 
Blinding ............................................................................................................. 15 
6.5 
Procedure .......................................................................................................... 15 
6.6 
Post-treatment Assessments ............................................................................ 15 
6.7 
Follow-up Assessments .................................................................................... 16 
6.7.1 
Unscheduled Follow-up Visits .................................................................... 17 
6.7.2 
Loss to Follow-up ....................................................................................... 17 
6.8 
Subject Withdrawal from Study ..................................................................... 17 
6.8.1 
Voluntary Withdrawal ................................................................................. 17 
6.8.2 
Involuntary Withdrawal .............................................................................. 17 
6.9 
End of Study ..................................................................................................... 18 
7. OUTCOMES ............................................................................................19 
7.1 
MAIN OUTCOMES ........................................................................................ 19 
7.1.1 
Time to Return to Normal Daily Activities within 3 Days .......................... 19 
7.1.2 
Time to Return to Work Among Employed Subjects ................................... 19 
7.1.3 
BCTQ-SSS Change at 3 Months ................................................................. 19 
7.1.4 
BCTQ-FSS Change at 3 Months ................................................................. 19 
7.1.5 
Numeric Pain Scale Change at 3 Months ................................................... 19 
7.1.6 
EQ-5D-5L Change at 3 Months .................................................................. 19 
7.1.7 
Device- or Procedure-related Adverse Events at 3 Months ....................... 20 
7.2 
Additional Outcomes........................................................................................ 20 
8. ADVERSE EVENTS ...............................................................................21 
8.1 
Serious Adverse Event ..................................................................................... 21 
8.2 
Unanticipated Adverse Device Effect ............................................................. 21 
8.3 
RelationShip of Adverse Events to the DEVICE OR Procedure ................. 22 
8.4 
Device Failures, Malfunctions and Near Incidents ....................................... 22 
8.5 
Reporting of Adverse Events ........................................................................... 22 

 
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8.6 
Independent Medical Reviewer ...................................................................... 23 
8.7 
Data Safety Monitoring Board ........................................................................ 23 
9. RISK-BENEFIT ANALYSIS .................................................................24 
9.1 
Risk Analysis ..................................................................................................... 24 
9.2 
Potential Benefits .............................................................................................. 24 
10. DATA ANALYSIS .................................................................................25 
10.1 Sample Size Justification ................................................................................. 25 
10.2 Analysis Populations ........................................................................................ 25 
10.3 Duration Variables ........................................................................................... 25 
10.4 Analysis Windows ............................................................................................ 25 
10.5 Data Analysis Methods .................................................................................... 26 
11. STUDY RESPONSIBILITIES AND MANAGEMENT ....................27 
11.1 Investigator Responsibilities ........................................................................... 27 
11.2 Subject Enrollment Process ............................................................................ 27 
11.3 Institutional Review Board .............................................................................. 28 
11.4 Informed Consent Form .................................................................................. 28 
11.5 Case Report Form ............................................................................................ 28 
11.6 Central Database .............................................................................................. 28 
11.7 Records .............................................................................................................. 29 
11.8 Reports .............................................................................................................. 29 
11.9 Sponsor Responsibilities .................................................................................. 30 
11.9.1 Confidentiality............................................................................................. 31 
11.9.2 Amending the Investigational Study Protocol............................................. 31 
11.9.3 Protocol Deviations .................................................................................... 31 
11.9.4 Site Noncompliance and Nonperformance ................................................. 31 
11.9.5 Device Accountability ................................................................................. 31 
12. STUDY MONITORING .......................................................................32 
13. REFERENCES ......................................................................................33 
 

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No. 90079-TP, Rev.05 
 
1. PROTOCOL SYNOPSIS 
Title 
Trial of Ultrasound guided carpal tunnel release versus Traditional Open Release 
(TUTOR) 
Purpose 
To compare the safety and effectiveness of carpal tunnel release with ultrasound 
guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients 
with symptomatic carpal tunnel syndrome (CTS) 
Study Design 
Multicenter randomized controlled trial of subjects with symptomatic CTS who 
will be randomized in 2:1 fashion to treatment with CTR-US or mOCTR 
Enrollment 
120 subjects will be enrolled in the study and randomized (2:1) to CTR-US 
(n≈80) or mOCTR (n≈40) 
Visit 
Schedule 
Post procedure remote subject-reported outcomes visits:  
1-14 days; 1, 3, 6, and 12 months 
Clinical Sites 
Up to 12 investigational sites located within the United States 
Inclusion 
Criteria 
1. ≥18 years of age 
2. Clinical diagnosis of unilateral or bilateral idiopathic CTS  
3. CTS-6 score >12 in target hand 
4. Absence of carpal tunnel symptoms in the contralateral hand that interfere 
with normal daily activities or work at the time of consent and are not 
anticipated to interfere with return to activities or return to work within at 
least 3 months post-operatively 
5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel 
region of the target hand measured by diagnostic ultrasound 
6. Prior failure of one or more nonsurgical treatment options for the target hand 
(e.g., physical activity modification, bracing, splinting, corticosteroid 
injection)  
7. Subject agrees to complete follow-up questionnaires over a 12-month period  
8. Subject has a valid mobile phone number and email address to receive and 
answer follow-up questionnaires 
Exclusion 
Criteria 
1. Prior surgery on the target wrist or hand with the exception of trigger finger 
that has clinically recovered 
2. History of prior surgical CTR procedure in the target hand 
3. History of prior surgical CTR in the contralateral hand within 3 months of 
enrollment or with persistent symptoms that interfere with normal daily 
activities or work at the time of consent 
4. Corticosteroid injection in the target wrist or hand within 6 weeks of study 
procedure date 
5. Presence of additional process in the target wrist or hand requiring additional 
intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, 
tenosynovectomy) 
6. Clinically significant degenerative arthritis of the upper limb (shoulder to 
hand) on the target side 
7. Clinically significant inflammatory disease (including tenosynovitis) of the 
upper limb (shoulder to hand) on the target side 

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No. 90079-TP, Rev.05 
 
8. Clinically significant trauma or deformity of the upper limb (shoulder to 
hand) on the target side 
9. Clinically significant vascular disease (including Raynaud’s phenomenon) of 
the upper limb (shoulder to hand) on the target side 
10. Clinically significant neurological disorder (including complex regional pain 
syndrome) of the upper limb (shoulder to hand) on the target side 
11. Planned surgical or interventional procedure on the contralateral wrist or 
hand 
12. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) 
13. Amyloidosis  
14. Chronic renal insufficiency requiring dialysis  
15. Diabetes not controlled by a stable dose of medication over the past three 
months 
16. Uncontrolled thyroid disease 
17. Pregnant or planning pregnancy in the next 12 months 
18. Workers’ compensation subjects 
19. Inability to provide a legally acceptable Informed Consent Form and/or 
comply with all follow-up requirements 
20. Subject has other medical, social or psychological conditions that, in the 
opinion of the investigator, preclude them from receiving the pre-treatment, 
required treatment, and post-treatment procedures and evaluations  
 
Main 
Outcomes 
• Return to normal daily activities within 3 days postoperatively 
• Time to return to work among employed subjects 
• Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) 
change at 3 months 
• Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ-FSS) 
change at 3 months 
• Numeric Pain Scale change at 3 months 
• EuroQol 5-Dimension 5-Level (EQ-5D-5L) change at 3 months 
• Device- or procedure-related adverse events at 3 months 
Principal 
Investigator: 
Kyle R. Eberlin, MD 
Division of Plastic Surgery 
Massachusetts General Hospital 
55 Fruit Street, WAC 435 
Boston, MA 02114 
Study 
Sponsor  
and Data 
Management: 
Sonex Health 
950 Blue Gentian Road, Suite 200 
Eagan, MN 55121 
Tel: 888-518-8780 
Email:  tutor-study@sonexhealth.com 
 
 
 

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No. 90079-TP, Rev.05 
 
2. LIST OF ABBREVIATIONS  
AAOS 
American Academy of Orthopedic Surgery 
AE 
Adverse event 
BCTQ 
Boston Carpal Tunnel Questionnaire 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CTR 
Carpal tunnel release  
CTR-US 
Carpal tunnel release with ultrasound guidance 
CTS 
Carpel tunnel syndrome  
DSMB 
Data Safety Monitoring Board 
ECTR 
Endoscopic carpal tunnel release 
EQ-5D-5L 
EuroQol 5-Dimension 5-Level 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act  
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IQR 
Interquartile range 
IRB 
Institutional Review Board  
MCID 
Minimal Clinically Important Difference 
mOCTR 
Mini-open carpal tunnel release 
OCTR 
Open carpal tunnel release 
PI 
Principal Investigator 
QDASH 
Quick form of the Disabilities of the Arm Shoulder and Hand 
SAE 
Serious adverse event 
SOP 
Standard Operating Procedure 
TCL 
Transverse carpal ligament 
UADE 
Unanticipated Adverse Device Effect  
 
 

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No. 90079-TP, Rev.05 
 
3. BACKGROUND AND OBJECTIVE 
Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy, affecting 
approximately 5% of the population 1.  A multitude of treatments are available to treat CTS, 
including activity modification, bracing/splinting, hand therapy, modalities (e.g., therapeutic 
lasers or ultrasound, iontophoresis), acupuncture, corticosteroid injections, and carpal tunnel 
release (CTR) surgery performed using an open or an endoscopic approach 2-7.  Currently, there 
is no universally accepted algorithm to guide treatment for patients suffering with CTS.  The 
American Academy of Orthopedic Surgery (AAOS) CTS Clinical Practice Guidelines reported 
that only three treatments are strongly supported in the literature: splinting, corticosteroid 
injections, and CTR 4.  Although some patients with mild-moderate symptoms are successfully 
treated with splinting and/or corticosteroid injections, those with progressive, refractory, or 
severe symptoms generally proceed to CTR for definitive management 2,3,5-9. 
 
The goal of CTR is to reduce median nerve pressure by dividing the transverse carpal ligament 
(TCL) while avoiding iatrogenic injury to surrounding neurovascular structures.  Among the 
~600,000 CTR procedures performed in the United States annually 1,10, most (70-80%) use a 
traditional open technique (OCTR) during which a palmar incision is made to dissect down to 
the TCL and transect it using a scalpel, scissors, or a similar cutting device 11-13.  The OCTR 
technique requires a relatively large (3-5 cm) incision and may be associated with a prolonged 
recovery period due to palmar pain and the need to protect the wound 12,14-17.   
 
Over time, there has been a trend to use smaller incisions (1-3 cm) to reduce surgical morbidity 
using mini-OCTR (mOCTR) or endoscopic CTR 11,16,17,19.  Because long-term outcomes and 
complication profiles are generally equivalent among these CTR procedures 18, factors related to 
patient recovery time such as time to return to normal activities and work absenteeism are 
important considerations that may assist in shared decision-making between physicians and 
patients. 
 
In recent years, multiple studies have demonstrated the feasibility of using ultrasound to perform 
CTR through even smaller incisions while maintaining or even improving visualization of the 
carpal tunnel region, including its at-risk neurovascular structures.  During CTR with ultrasound 
guidance (CTR-US), the carpal tunnel is typically accessed through a single small wrist or 
palmar incision <5 mm length and the TCL is transected using a small knife or similar cutting 
instrument while the carpal tunnel structures are continuously monitored using US.  To date, a 
total of 13 clinical studies have been published reporting results on over 1300 hands in over 1000 
patients at up to 2 years post-treatment comparing recovery time, effectiveness, and safety in 
subjects with CTS treated with CTR-US or mOCTR with US guidance 19-31.  Among these over 
1300 hands, there were no major neurovascular complications, and the clinical success rate was 
>95%.  Furthermore, two randomized controlled trials and one prospective non-randomized trial 
demonstrated superior early outcomes for CTR-US compared to mOCTR 21,24,28.  However, these 
trials were limited by small sample size, short follow-up duration, or both.  No randomized 
controlled trial comparing CTR-US to mOCTR has been performed with a sample size over 100 
patients and with at least 1 year of follow-up.  Thus, the objective of this randomized controlled 
trial is to compare the safety and effectiveness of CTR-US vs. mOCTR in a large cohort of 
patients (n=120) with symptomatic CTS followed for 1-year post-treatment. 

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4. DEVICE DESCRIPTION  
The UltraGuideCTR (Sonex Health, Inc., Eagan, MN) is a commercially available medical 
device specifically developed to facilitate CTR-US.  The device is a single-use, hand-held device 
that is inserted into the carpal tunnel through a small (typically < 5 mm) wrist incision using 
continuous US guidance.  The working tip of the UltraGuideCTR consists of two inflatable 
balloons that border a centrally located, retractable retrograde cutting knife. When inflated with 
sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm.  After the tip is 
positioned within the transverse safe zone, the balloons are inflated to create space in the carpal 
tunnel, the blade is activated, and the TCL is transected in a retrograde manner.  Following TCL 
transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is 
probed to ensure a complete release.  The entire procedure is performed using US guidance.  The 
first commercial CTR-US procedure with the device was performed in February 2017.   Since 
then, over 100 different physicians have been trained to use the UltraGuideCTR, who 
collectively have performed over 15,000 procedures.  Labeled images of the device are provided 
below. 
 
  
 
 
 
 

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5. SUMMARY OF PRIOR CLINICAL EXPERIENCE 
Representative prior experience with CTR-US using the UltraGuideCTR is derived from the 
APEX-CTR post market registry 31.  This multicenter, observational post-market registry 
enrolled patients treated with CTR-US in routine clinical practice in the United States.  Data 
collection in this registry began after FDA clearance to collect post-market safety and 
effectiveness information on the device and patient outcomes. The research methods adhered to 
the guidelines set forth in the Declaration of Helsinki.  This study was granted a waiver of 
consent exemption from WCG IRB (Puyallup, WA). 
 
The eligibility criteria were purposely broad to reflect a heterogenous sample of CTS patients 
treated in routine clinical practice.  Patient diagnosis was determined according to the practice 
patterns of each participating physician, all of whom were experienced in the diagnosis and 
management of CTS. CTS was diagnosed primarily on clinical grounds, with ancillary testing 
such as electrophysiological studies ordered at the discretion of the physician. Eligible patients 
were adults (age ≥18 years) who were treated with CTR-US and demonstrated a willingness to 
participate in the registry and participate in specified follow-up activities.  No limitations were 
imposed on maximum patient age, medical or surgical history, or clinical presentation. 
 
All patients were treated with CTR-US using the UltraGuideCTR device, which was inserted 
into the carpal tunnel through a small (typically <5 mm) wrist incision using real-time ultrasound 
guidance.  The physicians in this study represented a variety of specialties and procedural 
experience and completed a formal cadaver-based training program prior to performing CTR-US 
in clinical practice.  Factors such as patient selection, anesthesia, and postoperative care were 
determined by practice-specific preferences.  Face-to-face follow-up visits varied according to 
the usual practice patterns of each participating physician and were not dictated by the study. 
There was no requirement for return follow-up visits as all data were collected via text message, 
e-mail, or chart review. 
 
Patients completed a preoperative questionnaire, daily post-operative text message questions for 
up to 14 days post procedure, and emailed questionnaires at 2 weeks, 1 month, 3 months, and 6 
months postoperatively. Pre-treatment patient assessments included demographic data, medical 
and surgical history, work status, and patient-reported outcomes including the Quick form of the 
Disabilities of the Arm, Shoulder, and Hand Questionnaire (QDASH), and the BCTQ-SSS and 
Functional Status Scale (BCTQ-FSS). Return to normal activities and return to work were 
collected via daily text messages for the first 14 days. Thereafter, postoperative outcomes were 
collected via e-mail or text message and included QDASH, BCTQ-SSS, BCTQ-FSS, return to 
normal activities, return to work, and patient satisfaction. 
 
Co-primary endpoints of this study were QDASH, BCTQ-SSS, and BCTQ-FSS. The QDASH is 
an 11-item patient-reported questionnaire that has been validated for CTS where the total score 
ranges from 0 (indicating no disability) to 100 (indicating most severe disability) 32. The BCTQ 
is a CTS specific questionnaire consisting of 11 symptom severity questions and 8 functional 
status questions. Scoring for the BCTQ- SSS and BCTQ-FSS ranges from 1 to 5, with higher 
scores indicating more severe symptoms 33.  Minimal clinically important differences (MCIDs) 
for the postoperative change in patient-reported outcomes were 15 points for QDASH 34, 1.14 

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points for BCTQ-SSS 35, and 0.74 points for BCTQ-FSS 35.  Return to normal activities was 
ascertained by asking patients when they had returned to normal daily activities outside of work.  
Return to work was ascertained by asking employed patients when they had returned to work in 
any capacity, a definition that is commonly used among CTS studies 36,37.  Patient satisfaction 
with the procedure was reported on a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 
(very satisfied); a score of 4 or 5 indicated that a patient was satisfied with the procedure.  
Postoperative complications were recorded via chart review performed by the treating physician.  
 
Among 535 patients who enrolled in the registry and provided postoperative follow-up, data 
were available on 499 (93%) patients at 2 weeks, 475 (89%) at 1 month, 446 (83%) at 3 months, 
and 373 (70%) at 6 months.  The cohort of 373 patients with 6-month follow-up form the basis 
for this report.  Between November 2019 and July 2021, 373 patients (427 hands, mean age 55 
years, 71% female, 62% employed) underwent CTR-US at 24 sites in the United States.  A total 
of 329 (88.2%) procedures were performed using local anesthesia, 44 (11.8%) were performed 
using monitored anesthesia care, and no procedures were performed using general anesthesia.  
There were 217 unilateral CTR-US procedures, 51 bilateral staged CTR-US procedures, and 54 
bilateral simultaneous CTR-US procedures.  Bilateral simultaneous procedures consisted of 
14.5% of cases and 25.3% of treated hands.   
 
Patient-reported measures of symptom severity and physical function demonstrated rapid 
improvement following CTR-US.  Mean QDASH scores were 41.7±20.1 at baseline, 21.4±15.9 
at 2 weeks, 17.7±15.1 at 1 month, 13.3±15.0 at 3 months, and 11.0±15.2 at 6 months.  QDASH 
scores decreased by 20.3 (95% CI: 17.5 to 23.0) points at 2 weeks and 30.8 (95% CI: 28.1 to 
33.4) points at 6 months (p<0.001 at each follow-up interval).   
 
Mean BCTQ-SSS scores were 3.0±0.7 at baseline, 1.7±0.6 at 2 weeks, 1.7±0.6 at 1 month, 
1.5±0.6 at 3 months, and 1.4±0.6 at 6 months.  BCTQ-SSS scores decreased by 1.3 (95% CI: 
1.2-1.4) points at 2 weeks and 1.6 (95% CI: 1.5-1.7) points at 6 months (p<0.001 at each follow-
up interval).  Mean BCTQ-FSS scores were 2.4±0.8 at baseline, 1.7±0.6 at 2 weeks, 1.6±0.5 at 1 
month, 1.4±0.5 at 3 months, and 1.3±0.5 at 6 months.  BCTQ-FSS scores decreased by 0.7 (95% 
CI: 0.5-0.8) points and 1.0 (95% CI: 0.9-1.1) points at 2 weeks and 6 months, respectively 
(p<0.001 at each follow-up interval).  
 
The median time to return to normal activities following CTR-US was 3 days (interquartile range 
[IQR]: 2-5 days), with 96.5% of patients reporting return to normal activities within 2 weeks of 
the procedure.  Among employed patients, the median time to return to work following CTR-US 
was 5 days (IQR: 3-9 days), with 92.3% of patients reporting return to work within 2 weeks of 
the procedure.  The median time to return to work based on employment type was 4 days (IQR: 
3-6 days) for desk-based occupations, 6 days (IQR: 4-11 days) for light manual occupations, and 
5 days (IQR: 3-14 days) for heavy manual occupations.  The percentage of patients who were 
satisfied or very satisfied with the procedure was 91.6% at 2 weeks, 88.2% at 1 month, 88.0% at 
3 months, and 89.8% at 6 months.   
 
Among 346 (93%) patients with available complication data, no major neurovascular 
complications were reported.  Specifically, there was 1 (0.3%) incomplete release confirmed 
during reoperation and no reports of superficial infection, deep infection, arterial laceration, or 
permanent nerve injury. 

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Overall, the results of the APEX-CTR post market registry confirmed that patients treated with 
CTR-US reported clinically meaningful improvements in symptoms and function, rapid return to 
normal activities, and minimal work absenteeism, with an excellent safety profile.  Given the 
promising results with CTR-US in this registry, comparison of clinical outcomes with CTR-US 
vs. mOCTR in a randomized controlled trial is warranted. 
 
 

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6. STUDY PROCEDURES 
6.1 
INVESTIGATIONAL SITE SELECTION 
Investigational sites will be selected based on the availability of the subject pool to be included 
in the study, the ability of the study site to perform the research in compliance with the 
investigational plan, and agreement to comply with the institutional review board (IRB) 
requirements.  All investigators will be board certified orthopedic or plastic surgeons 
experienced in the diagnosis and treatment of CTS, including CTR-US and mOCTR.  Each 
surgeon will complete a structured training program in musculoskeletal ultrasound including 
ultrasound machine controls, sonographic anatomy of the carpal tunnel region, identification and 
cross-sectional measurement of the median nerve, and CTR-US using the UltraGuideCTR 
device.  In addition, all investigators must have treated a minimum of 10 procedures using CTR-
US and 10 patients using mOCTR prior to treating subjects in the clinical trial. 
 
6.2 
SUBJECT SELECTION 
Patients with suspected CTS will be consecutively evaluated for study eligibility at each site.   
Patients must meet all inclusion criteria and no exclusion criteria to be enrolled in the trial.   
6.2.1 Inclusion Criteria 
1. ≥18 years of age 
2. Clinical diagnosis of unilateral or bilateral idiopathic CTS  
3. CTS-6 score >12 in target hand 
4. Absence of carpal tunnel symptoms in the contralateral hand that interfere with normal 
daily activities or work at the time of consent and are not anticipated to interfere with 
return to activities or return to work within at least 3 months post-operatively 
5. Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the 
target hand measured by diagnostic ultrasound 
6. Prior failure of one or more nonsurgical treatment options for the target hand (e.g., 
physical activity modification, bracing, splinting, corticosteroid injection)  
7. Subject agrees to complete follow-up questionnaires over a 12-month period  
8. Subject has a valid mobile phone number and email address to receive and answer 
follow-up questionnaires 
6.2.2 Exclusion Criteria 
1. Prior surgery on the target wrist or hand with the exception of trigger finger that has 
clinically recovered 
2. History of prior surgical CTR in the target hand 
3. History of prior surgical CTR in the contralateral hand within 3 months of enrollment or 
with persistent symptoms that interfere with normal daily activities or work at the time of 
consent 
4. Corticosteroid injection in the target wrist or hand within 6 weeks of study procedure date 
5. Presence of additional process in the target wrist or hand requiring additional intervention 
beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy) 

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6. Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the 
target side 
7. Clinically significant inflammatory disease (including tenosynovitis) of the upper limb 
(shoulder to hand) on the target side 
8. Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the 
target side 
9. Clinically significant vascular disease (including Raynaud’s phenomenon) of the upper 
limb (shoulder to hand) on the target side 
10. Clinically significant neurological disorder (including complex regional pain syndrome) 
of the upper limb (shoulder to hand) on the target side 
11. Planned surgical or interventional procedure on the contralateral wrist or hand 
12. Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) 
13. Amyloidosis  
14. Chronic renal insufficiency requiring dialysis  
15. Diabetes not controlled by a stable dose of medication over the past three months  
16. Uncontrolled thyroid disease 
17. Pregnant or planning pregnancy in the next 12 months 
18. Workers compensation subjects 
19. Inability to provide a legally acceptable Informed Consent Form and/or comply with all 
follow-up requirements 
20. Subject has other medical, social or psychological conditions that, in the opinion of the 
investigator, preclude them from receiving the pre-treatment, required treatment, and 
post-treatment procedures and evaluations  
6.2.3 Screen Failures 
Participants who are consented to participate in the clinical trial, but who do not meet one or 
more criteria required for participation in the trial during the screening procedures, are 
considered screen failures.  Screen failures will be immediately discontinued from the trial and 
will not be randomized to receive CTR-US or mOCTR.  Participants who are discontinued from 
the study due to screen failure may not be reconsidered for study enrollment at a later date.  
Study sites will document screen failures by recording the date of screening, an anonymized 
patient identifier, and the primary inclusion and/or exclusion criterion failure that resulted in the 
decision to discontinue the patient from the study.   
6.2.4 Timing of Patient Screening 
All baseline testing and evaluations should be performed as close to the time of the procedure as 
possible.  If the subject’s procedure date is more than 30 days from the screening evaluation, 
subject screening validated questionnaires must be repeated to ensure accuracy of baseline 
condition at the time of procedure.   
 
6.3 
RANDOMIZATION  
Subjects meeting all study inclusion/exclusion criteria after their screening evaluation will be 
randomized.  This study will enroll 120 subjects who will be randomized in 2:1 fashion to 
receive CTR-US (n≈80) or mOCTR (n≈40).  The randomization sequence for this trial will be 
computer-generated by the electronic data capture system (Viedoc).  The randomization 

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sequence will be stratified by site with variable block sizes.  Treatment assignment will be 
concealed until it is presented to authorized site personnel at the time of randomization.  Only 
randomized and treated subjects will be considered enrolled in the study.  Randomized patients 
who do not receive their assigned treatment will be discontinued from the trial. 
 
6.4 
BLINDING 
Owing to obvious differences in surgical technique, it is not possible to blind the treating 
physicians.  Owing to notable visual differences in the postoperative scar between surgical 
techniques (3-5 mm for CTR-US and approximately 3 cm for mOCTR), it is not possible to blind 
the subjects.  Owing to the fact that all data collected in this trial will be self-reported, it is not 
possible to blind outcome assessors (i.e., subjects). 
 
6.5 
PROCEDURE 
The key procedural steps involved in CTR-US are listed below.   
1. Using direct US visualization, identify relevant anatomical structures within the carpal 
tunnel. 
2. Dissect synovial tissue from the undersurface of the TCL via hydrodissection. 
3. Insert the device through a small wrist incision and advance into the carpal tunnel. 
4. Position the tip of the device distal to the distal TCL so that the TCL Blade will engage 
the distal TCL. 
5. Confirm the position of the device under ultrasound. 
6. Activate the Stealth MicroGuard balloons to create space within the carpal tunnel. 
7. Deploy the TCL Blade by moving the slide button proximally to transect the TCL from 
distal to proximal until the TCL Blade passes into its proximal recessed position. 
8. With the device or an elevator, probe the TCL to ensure a complete release. 
Complete procedural details are provided in the Instructions for Use 
(https://sonexhealth.com/physicians/ultraguidectr/instructions-for-use). 
 
6.6 
POST-TREATMENT ASSESSMENTS 
Postoperative patient care instructions will be standardized for each treatment group and among 
all participating sites to minimize bias. Investigators will instruct subjects to “participate in 
activities and return to work, as tolerated, based on pain, function, and wound healing status”. 
   
 
 
 

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6.7 
FOLLOW-UP ASSESSMENTS 
A list of the study assessments performed by the investigational site at each study interval is 
provided in the table below. 
 
Assessment 
Baseline 
Screening 
Procedure 
Post-
Op 
Day 
7 
Day 
14 
1 
month 
3 
months 
6 
months 
12 
months 
Demographics 
√ 
 
 
 
 
 
 
 
 
Ultrasound median 
nerve cross-sectional 
measurement  
√ 
 
 
 
 
 
 
 
 
CTS-6  
(both hands) 
√ 
 
 
 
 
 
 
 
 
Randomization 
√ 
 
 
 
 
 
 
 
 
Procedure 
 
√ 
 
 
 
 
 
 
 
Image of incision 
 
√ 
 
 
 
 
 
 
 
Adverse events 
 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
 
 
A list of the patient reported outcomes provided by the patient at each study interval is provided 
in the table below. 
 
Assessment 
Baseline 
Screening 
Procedure 
 
Post-Op 
Daily 
1-14 
1 
month 
3 
months 
6 
months 
12 
months 
Demographics 
√ 
 
 
 
 
 
 
 
Medical history 
√ 
 
 
 
 
 
 
 
BCTQ-SSS 
√ 
 
 
√1 
√ 
√ 
√ 
√ 
BCTQ-FSS 
√ 
 
 
√1 
√ 
√ 
√ 
√ 
EQ-5D-5L 
√ 
 
 
√1 
√ 
√ 
√ 
√ 
Numeric Pain Scale 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
Procedure 
 
√ 
 
 
 
 
 
 
Images of wound healing 
 
 
 
√2 
√ 
√ 
√ 
√ 
Return To Activities (RTA) 
 
 
 
√ 
√ 
√ 
√ 
√ 
Return To Work (RTW) 
 
 
 
√ 
√ 
√ 
√ 
√ 
Pain Medication 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
√ 
1Collected at 14-day evaluation 
2Collected at Day 7 and Day 14 
 
 

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6.7.1 Unscheduled Follow-up Visits 
If subjects are seen for unscheduled visits because of an AE or additional hand surgery, 
appropriate Case Report Form(s), will be completed, if applicable. 
6.7.2 Loss to Follow-up 
If a subject fails to comply with follow-up evaluations, the investigational site must make at least 
two repeated attempts to contact the subject.  Each attempt to contact the subject and the method 
used (e.g., telephone contact, registered letter) must be documented in the subject’s records.   
 
6.8 
SUBJECT WITHDRAWAL FROM STUDY 
6.8.1 Voluntary Withdrawal 
A subject may voluntarily withdraw from the study at any time.  If a subject officially withdraws 
from the study, the investigator must ensure that the reason for the withdrawal is documented.  If 
the subject had an AE, the subject should be followed until the resolution of the AE, if possible.  
Data from these subjects will be included in the analysis up to the point of each subject’s 
withdrawal. 
6.8.2 Involuntary Withdrawal 
A subject also may be withdrawn by the investigator if the investigator determines that continued 
subject participation in the study will have a negative effect on the safety of the subject.  Data 
obtained up to the date of subject withdrawal will be included in the study.   
6.8.2.1 During First 3 months following Surgery  
• 
Subjects who have any subsequent surgery on either hand during the first 3 months 
following their procedure will be withdrawn from the study.   
6.8.2.2 After 3 month eVisit : 
• 
Treated Subjects  
o Surgery in the Contralateral Hand - Subjects who have subsequent surgery on the 
contralateral hand (i.e., non-study hand), including CTR, will not be involuntarily 
withdrawn from the study.  Note that a subsequent CTR in the contralateral hand 
is still not eligible for enrollment in TUTOR. 
o Surgery in the Study Target Hand –  
• 
Subjects who have subsequent surgery on the TUTOR hand that includes 
the wrist or carpal tunnel region, metacarpals, or thumb (with the 
exception of trigger thumb release) will be withdrawn from the study.   
• 
Subjects who have subsequent finger surgery (including trigger finger 
release) or trigger thumb release that does not affect the wrist or carpal 
tunnel region will not be withdrawn from the study.  
. 
 

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6.9 
END OF STUDY 
Subjects may exit the study at the end of the study (i.e., the study is discontinued by the Sponsor) 
or when the subject has completed the 12-month follow-up visit, whichever comes first, unless 
the subject opted to find an alternative treatment.   
 
An End of Study CRF will be completed at the time the study is completed, discontinued, or lost 
to follow-up for each subject. 
 
 
 

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7. OUTCOMES 
 
7.1 
MAIN OUTCOMES 
7.1.1 Time to Return to Normal Daily Activities within 3 Days 
Time to return to normal daily activities will be collected through the ViedocMe ePRO module 
which asks whether the subject has returned to normal daily activities outside of work.  
Reminders will be sent to the subjects either by email or text messaging to minimize the risk of 
missing data.  The time to return to normal daily activities will be defined as the number of days 
between treatment and the time the subject reports returning to normal daily activities, 
irrespective of work status.   
7.1.2 Time to Return to Work Among Employed Subjects 
Among study subjects who report full-time or part-time employment, time to return to work will 
be ascertained through the ViedocMe ePRO module by asking whether the subject has returned 
to work in full or limited capacity.  Return to work within 3 days postoperatively will represent a 
secondary endpoint of the study.  The time to return to work will be defined as the number of 
days between treatment and the time the subject reports returning to work in any capacity. 
7.1.3 BCTQ-SSS Change at 3 Months  
The BCTQ is a CTS specific questionnaire that has been shown to be highly reproducible, 
internally consistent, valid, and responsive to clinical change in CTS and subject status post-
CTR.  The BCTQ consists of 11 symptom severity questions (BCTQ-SSS).  Scoring for the 
BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is 
calculated as the mean of each response.  The between-group mean difference in BCTQ-SSS 
change scores at the 3-month follow-up will represent a secondary endpoint of the study. 
7.1.4 BCTQ-FSS Change at 3 Months  
The BCTQ additionally consists of 8 functional status questions (BCTQ-FSS).  Scoring for the 
BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is 
calculated as the mean of each response.  The between-group mean difference in BCTQ-FSS 
change scores at the 3-month follow-up will represent a secondary endpoint of the study. 
7.1.5 Numeric Pain Scale Change at 3 Months 
Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents 
“no pain” and 10 represents “worst possible pain”.  The between-group mean difference in 
Numeric Pain Scale change scores at the 3-month follow-up will represent a secondary endpoint 
of the study. 
7.1.6 EQ-5D-5L Change at 3 Months 
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) is a generic preference-based questionnaire 
developed by the EuroQol Group to measure health-related quality of life.  The EQ-5D-5L 
measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, 
and anxiety/depression.  Each dimension is scored on a 5-level severity ranking consisting of: no 

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problems, slight problems, moderate problems, severe problems, unable to/extreme problems.  
The between-group mean difference in EQ-5D-5L change score at the 3-month follow-up will 
represent a secondary endpoint of the study. 
7.1.7 Device- or Procedure-related Adverse Events at 3 Months 
Adverse events (AEs) occurring within 90 days of treatment and that are adjudicated as 
definitely related or probably related to the device, or definitely related or probably related to the 
procedure will be included in this endpoint.  The incidence of device- or procedure-related AEs 
within 90 days of treatment in each study group will represent a secondary endpoint of the study. 
 
7.2 
ADDITIONAL OUTCOMES 
Additional outcomes of the study will include: 
• Median time to return to normal activities 
• Median time to return to work 
• BCTQ-SSS change at 2 weeks, 1 month, 6 months, and 12 months 
• BCTQ-FSS change at 2 weeks, 1 month, 6 months, and 12 months 
• Numeric Pain Scale change at 2 weeks, 1 month, 6 months, and 12 months 
• EQ-5D-5L change at 2 weeks, 1 month, 6 months, and 12 months 
• Device- or procedure-related AEs at 2 weeks, 1 month, 6 months, and 12 months 
• Serious device- or procedure-related AEs at 2 weeks, 1 month, 3 months, 6 months, and 
12 months 
 
 
 

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8. ADVERSE EVENTS 
An AE is defined as any adverse change (i.e., de novo or preexisting condition) from the 
subject’s baseline medical condition occurring after the initial procedural incision has been 
initiated.  Any AE which resolved and then recurred will be reported as a separate AE.  A pre-
specified listing of AEs will be documented on the Adverse Event eCRF. 
 
8.1 
SERIOUS ADVERSE EVENT 
A serious adverse event (SAE) is defined as one that suggests a significant hazard or side effect, 
regardless of the relationship to the device or procedure.  This includes, but may not be limited 
to, any event that: 
• Results in death  
• Is life threatening, or places the participant at immediate risk of death from the event as it 
occurred 
• Requires or prolongs hospitalization  
• Causes persistent or significant disability or incapacity  
• Results in congenital anomalies or birth defects  
• Is another condition which investigators judge to represent significant hazards 
 
Important medical events may be considered serious by the investigator although they may not 
be immediately life threatening or result in death or prolong hospitalization.  Such important 
medical events are those that may jeopardize the subject, require intervention to prevent one of 
the outcomes listed above, or result in urgent investigation.  
  
SAEs should be reported to the study Sponsor as soon as possible (24 hours recommended), but 
no more than 10 working days after the date the site becomes aware of the event. 
 
Sites are also required to adhere to the reviewing IRB requirements for reporting of SAEs. 
 
8.2 
UNANTICIPATED ADVERSE DEVICE EFFECT 
An unanticipated adverse device effect (UADE) is any serious adverse effect on the health or 
safety of a subject, any life-threatening problem or death caused by, or associated with a device, 
if such effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan (e.g., ICF, Study Protocol, Instructions for Use (IFU), 
publications, etc.), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
 
If an unanticipated adverse effect associated with the device occurs, the investigator shall notify 
the Sponsor and the IRB as soon as possible.   
 
The Sponsor will investigate the event and notify the FDA and all other participating IRBs and 
investigators.  Should the Sponsor determine that an unanticipated adverse effect presents an 

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unreasonable risk to all participating subjects, the Sponsor will suspend the clinical investigation 
and notify all participating investigators, IRBs, country regulatory bodies and FDA.  
 
8.3 
RELATIONSHIP OF ADVERSE EVENTS TO THE DEVICE OR PROCEDURE 
A description of how an AE relates to the study device or procedure will be reported on the 
Adverse Event CRF. 
 
• A device-related AE is directly attributable to the device or to improper use of the device.   
• A procedure-related AE is directly attributable to the procedure, irrespective of the device, 
including complications from anesthesia or other procedures incidental to the main 
procedure. 
 
The relationship of the AE to the device or procedure will be determined by the Investigator using 
the following definitions: 
 
• Definite:  The AE follows a reasonable temporal sequence from the time of the index 
procedure, which includes AEs that occur during the index procedure or during the 
follow-up period. 
• Probable:  The AE follows a reasonable temporal sequence from the time of the index 
procedure, and the possibility can be excluded that factors other than the index procedure, 
such as underlying disease, concomitant drugs, or concurrent treatment caused the AE. 
• Possible:  The AE follows a reasonable temporal sequence from the time of the index procedure 
and the possibility of index procedure involvement cannot be excluded.  However, other factors 
such as underlying disease, concomitant medications, or concurrent treatment are presumable. 
• Unlikely:  The AE has an improbable temporal sequence from the time of the index 
procedure, or such AE can be reasonably explained by other factors, including 
underlying disease, concomitant medication, or concurrent treatment. 
• Not related: The AE has no temporal sequence from the time of the index procedure, or it 
can be explained by other factors, including underlying disease, concomitant medication, 
or concurrent treatment. 
 
8.4 
DEVICE FAILURES, MALFUNCTIONS AND NEAR INCIDENTS 
Device failures or malfunctions will be reported to Sonex Health by the clinical sites.  If the 
failure or malfunction results in an AE, the event shall be reported to the Sponsor within two (2) 
working days after the Investigator becomes aware of the event and reported to the IRB (if 
required) within the IRB required timeframe.  The device involved in the incident should be 
returned to the Sponsor for evaluation.   
 
8.5 
REPORTING OF ADVERSE EVENTS 
AEs will be recorded on the Adverse Event CRF and described by (a) duration (onset and 
resolution dates); (b) relationship to the study device or procedure; (c) action taken to resolve the 
event; (d) outcome of the event; and (e) whether or not such event is considered to have been 

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serious.  Additional information, such as procedural notes, treatment notes, or a signed clinical 
summary may be required as supporting documentation for the reported AE. 
 
During the study, all deaths must be reported to the Sponsor within 48 hours and should also be 
reported on the End of Study CRF.  A copy of the subject’s death records, medical records for 
the events that led to the subject’s death, and a death certificate (if available) should be provided. 
 
Determination of whether a subject experienced an AE can be made in three different ways.  
First, an AE can be documented by the site during the study procedure.  Second, a subject may 
report an AE directly via phone call to the investigative site.  Third, an AE can be identified by 
the site during the review of the subject-uploaded wound healing images. If the site identifies a 
potential AE based on image review or is notified of a potential AE by the subject, confirmation 
of the AE will occur by a phone call with the subject or, if necessary, by asking the subject to 
return for a follow-up clinical evaluation.   
 
8.6 
INDEPENDENT MEDICAL REVIEWER 
Evaluation and adjudication of all AEs will be performed on an ongoing basis by an independent 
medical reviewer.  The independent medical reviewer will review AEs for AE classification, 
seriousness, and relationship to the device or procedure.  Discrepancies between the 
investigational site and the independent medical reviewer will be handled by discussion, with the 
determination by independent medical reviewer serving as the final classification. 
 
8.7 
DATA SAFETY MONITORING BOARD  
A Data Safety Monitoring Board (DSMB) will oversee enrollment and safety of the subjects for 
the study.  Members of DSMB will be independent of the sponsor and investigational sites.  The 
DSMB for the study will consist of three (3) clinicians with expertise in orthopedic or plastic 
surgery, and with experience and expertise in clinical trials.  The DSMB will convene at least 
once during the subject enrollment period and will review, at a minimum, subject enrollment 
status and incidence of AEs.  Based on a review of these data, the DSMB will advise the Sponsor 
to continue the trial with no modification, or to modify the trial as appropriate if enrollment or 
safety concerns are identified. 
 
 
 
 
 

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9. RISK-BENEFIT ANALYSIS 
9.1 
RISK ANALYSIS 
Complications and risks that exist for other CTR treatments may also exist for the 
UltraGuideCTR technique.  The UltraGuideCTR technique has undergone extensive risk 
analysis testing and is designed with safeguards built into the device to mitigate the serious risks.  
The full list of anticipated adverse events is provided on the Adverse Event CRF.  All 
complications that can occur with mOCTR may also occur with CTR-US. 
 
9.2 
POTENTIAL BENEFITS 
The data obtained from this study will be used to document the safety and effectiveness of 
UltraGuideCTR and compare it to mOCTR.  The data derived from this study may benefit 
individuals with CTS in the context of a shared-decision making process when contemplating 
CTR.  In addition, subjects potentially could directly benefit from participation in this study.  
UltraGuideCTR is designed to provide relief from CTS through a less invasive approach than 
mOCTR.  Previous publications reported that patients may experience significant symptom 
relief and return to activities within 3-5 days post-procedure, which is faster than typically 
reported for mOCTR. 
 
 

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10. DATA ANALYSIS 
This is a multicenter, randomized, controlled trial designed to evaluate the safety and 
effectiveness of CTR-US compared to mOCTR in treating subjects with symptomatic CTS.  
Eligible subjects will be randomized (2:1) to receive CTR-US (n≈80) or mOCTR (n≈40). 
 
10.1 SAMPLE SIZE JUSTIFICATION 
The results of the power analysis provided a sample size consisting of 102 evaluable subjects.  
Group sample sizes of 68 and 34 achieve 80% power to reject the null hypothesis of zero effect 
size when the population effect size is 0.60 and alpha is 0.05 using a two-sided two-sample 
equal-variance t-test with a 2:1 randomization allocation.  To account for reasonable subject 
attrition, 120 subjects (n≈80 CTR-US, n≈40 mOCTR) will be enrolled in the trial.  
 
10.2 ANALYSIS POPULATIONS  
The primary statistical analyses will be performed on a modified intention-to-treat population, 
which will be comprised of all subjects who meet all study eligibility criteria, are subsequently 
randomized, and receive their assigned treatment.  Randomized subjects who withdraw from the 
study prior to treatment or who receive the incorrect treatment will not be included in the 
modified intention-to-treat population. 
 
10.3 DURATION VARIABLES 
Study day 0 is the day the subject receives CTR-US or mOCTR.  Postoperative study day will be 
calculated relative to day 0 as follows: 
 
Study Day = (Date of Event – Date of Treatment) 
 
10.4 ANALYSIS WINDOWS 
Study data will be categorized into discrete, contiguous reporting windows to ensure that all 
available data are included in the analyses.  The analysis windows for this study are defined 
below: 
 
Study Visit 
Target Days 
Analysis Window 
Treatment 
0 
0 
2 weeks 
14 
7-22 
1 month 
30 
23-60 
3 months 
90 
61-135 
6 months 
180 
136-270 
12 months 
365 
271-450 
 
 

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10.5 DATA ANALYSIS METHODS 
Baseline data will be analyzed using descriptive statistics.  Continuous data will be summarized 
using mean and standard deviation for normally distributed data, median and interquartile range 
for non-normally distributed data, and counts and percentages for categorical data.  For 
categorical variables, percentages will be calculated based on non-missing data. 
 
The percentage of patients in each treatment group that return to normal daily activities within 3 
days postoperatively, and the percentage of employed patients in each treatment group that return 
to work within 3 days postoperatively will be reported and compared using the Fisher’s exact test.  
These outcomes will also be reported as the median and interquartile range in each treatment 
group.  Due to the likelihood that the data distribution may be positively skewed, the 
nonparametric Mann-Whitney U test will be the statistical test used to assess these endpoints.   
 
Differences between the CTR-US and mOCTR groups with respect to longitudinally measured 
continuous outcomes (i.e. BCTQ-SSS, BCTQ-FSS, Numeric Pain Scale, EQ-5D-5L) will be 
analyzed using mixed model analysis and adjusting for the baseline score.   
 
Adverse events will be reported using counts, percentages and exact 95% confidence intervals 
using Clopper-Pearson’s method.  The incidence of AEs in each group will be calculated on a 
per-subject basis and analyzed using Fisher’s exact test. 
 
Statistical analyses will be performed using a two-sided hypothesis test at a 5% level of 
significance.  No adjustments for multiplicity are planned.  Missing data imputation will not be 
performed. 
 
 
 

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11. STUDY RESPONSIBILITIES AND MANAGEMENT 
This study will be performed in accordance with all requirements set forth in the U.S. 
regulations, 21 Code of Federal Regulations (CFR) Parts 812, 50, 54, and 56, the Declaration of 
Helsinki, and any other applicable local laws, regulations, or guidelines.  
 
11.1 INVESTIGATOR RESPONSIBILITIES  
Each investigator will be responsible for ensuring the investigation is conducted according to all 
signed agreements, the study protocol, IRB requirements, and applicable laws and regulations.  
Investigators may not begin enrollment until the Sponsor or its designee receives and approves 
(when necessary) the following documents: 
 
• 
Signed Investigator Agreement 
• 
Financial disclosure forms for all participating investigators 
• 
IRB roster (or IRB registration number from the Office of Human Research Protection) 
• 
IRB protocol and ICF approvals 
• 
Investigators’ current curricula vitae and medical license 
• 
Signed Site Delegation Log 
 
It is acceptable for Investigators to delegate one or more of the above functions to a Co- or Sub-
Investigator, or a trained Research Coordinator; however, the Investigator remains responsible 
for the proper conduct of the clinical investigation, including obtaining and documenting proper 
study informed consent, collecting all required data, submitting accurate and complete CRFs, etc. 
 
At each study site, appropriate procedures must be followed to maintain subject confidentiality 
according to appropriate local regulations (e.g., Health Insurance Portability and Accountability 
Act (HIPAA) in the U.S.).  Each site may have its own internal procedures or requirements for 
use and release of subject medical information in research studies.  Each Investigator is 
responsible for obtaining appropriate approvals, consents, or releases of medical information as 
dictated by their relevant subject privacy laws. 
 
The study is not transferable to other sites attended by the Investigator unless prior approval is 
obtained from the appropriate IRB and the Sponsor. 
 
11.2 SUBJECT ENROLLMENT PROCESS 
All study candidates must appropriately consent to participate in the study, as administrated by 
qualified study site personnel using an IRB and Sponsor-approved informed consent form (ICF) 
prior to beginning any aspect of the study procedure or tests that are not standard of care for the 
site.  Investigational sites will be required to document the consent process within each enrolled 
subject’s medical record.   
 

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11.3 INSTITUTIONAL REVIEW BOARD 
Investigators must submit the study protocol to the Institutional Review Board (IRB) and obtain 
the IRB’s written approval before being allowed to conduct and participate in the study.  Each 
Investigator is responsible for fulfilling any conditions of approval imposed by the IRB, such as 
regular reporting, study timing, etc.  Investigators will provide the Sponsor with copies of such 
approvals and reports. 
 
11.4 INFORMED CONSENT FORM 
The Sponsor will provide a template informed consent form (ICF) to each study site for IRB 
submission.  The template may be modified to suit the requirements of the individual study site, 
but the Sponsor must pre-approve all changes to the ICF prior to initial submission to the IRB.   
 
Each Investigator or assigned designee must administer this approved ICF to each prospective 
study subject and obtain the subject's signature or a legally approved designee’s signature along 
with the date of consent prior to enrollment in the study.  The ICF must be obtained in 
accordance with the applicable guidelines on 21 CFR 50, 52 and 56, the Declaration of Helsinki, 
ISO 14155 or local regulations and laws, whichever represents the greater protection of the 
individual.  Subjects must be informed about their right to withdraw from the study at any time 
and for any reason without sanction, penalty, or loss of benefits to which the subject is otherwise 
entitled and be informed that withdrawal from the study will not jeopardize their future medical 
care.  A copy of their signed ICF must be given to each subject enrolled in the study.  The 
institutional standard subject consent form does not replace the TUTOR study ICF. 
 
11.5 CASE REPORT FORM 
The Sponsor will provide standardized case report forms (CRFs) for each individual subject.  
The CRFs will be electronic (EDC, 21 CRF Part 11 compliant), and will be used to record study 
data, and are an integral part of the study and subsequent reports.   
 
The electronic CRFs for individual subjects will be provided by the Sponsor via a web portal.  
After the data has been submitted, reviewed, and centrally monitored, corrections will be 
initiated via automatic data queries and/or manual data queries answered by appropriate study 
site personnel.  The Investigator will provide his/her electronic signature on the appropriate 
eCRFs in compliance with local regulations. 
 
11.6 CENTRAL DATABASE 
All subject data will be collected and compiled in a limited access secure electronic data capture system 
(EDC).  Appropriate quality control measures will be established to ensure accurate and complete 
transfer of information from the study documentation to the central database. 
 

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11.7 RECORDS 
Each Investigator must maintain the following accurate, complete, and current records relating to 
the conduct of the study investigation.  The final responsibility for maintaining such records 
remains with the Investigator.  These records include, but not limited to: 
 
• All signed agreements 
• IRB approval letter(s) 
• Approved ICF template 
• Records of AEs, including supporting documents 
• Records of protocol deviations, including supporting documents 
• Records of each subject’s case history, including study required CRFs, signed 
ICF, all relevant observations of AEs, the condition of each subject upon entering 
and during the investigation, relevant medical history, the results of all diagnostic 
testing, etc. 
• Signature authorization and delegation log 
• Any other records that applicable regulation requires to be maintained 
 
11.8 REPORTS  
The table below lists those reports that are the investigator's responsibility to deliver to the 
Sponsor.  Each study investigator must follow the IRB reporting requirements for their 
respective site.  If applicable regulations or IRB requirements mandate stricter reporting 
requirements than those listed, the stricter requirements must be followed. 
 
 
 
 

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Type of Report 
Prepared by PI for 
Notification Time Frame 
UADE 
 
Sponsor, IRB 
 
Within 10 working days of knowledge 
Death 
Sponsor, IRB 
Written reports (e.g., via e-mail) 
within 48 hours 
SAE  
Sponsor 
 
IRB, if required 
Within 10 working days of knowledge  
 
Per IRB requirement 
Device malfunction 
with clinical sequelae 
Sponsor 
 
IRB, if required 
Within 48 hours via written 
communication.  Return the device to 
sponsor within 48 hours. 
Serious protocol 
deviations (e.g., ICF 
not obtained, to 
protect the life or 
physical well-being of 
a subject in an 
emergency) 
Sponsor 
 
IRB, if required 
Within 5 working days of knowledge 
 
Per IRB requirement 
Withdrawal of IRB 
approval 
Sponsor 
 
Within 5 working days of knowledge 
Annual progress 
report 
Sponsor, IRB 
Annually 
Final report 
Sponsor, IRB 
Within 6 months of study completion 
or termination 
Note: Institutional IRBs may require more stringent reporting requirements that those listed in 
this table. 
 
11.9 SPONSOR RESPONSIBILITIES  
Sonex Health is the Sponsor of this study.  The Sponsor’s responsibilities in the study include: 
• Selecting qualified Principal Investigator(s), all clinical investigators and study sites, and 
other consultants (e.g., monitors) who participate in the study. 
• Provide study protocol, device, and GCP training to participating study sites, in quantities 
sufficient to support study activities, per agreements executed with the study sites. 
• Provide financial support to each study site. 
• Follow/promote all regulatory standards per appropriate regulations for study sites, and 
other participants, and ensure compliance through central monitoring. 
• Retain ownership of all clinical data generated in this study and control the use of the 
data for appropriate purposes only.   
• Review and approve publication of study results in the literature. 
 
 

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11.9.1 Confidentiality 
All information and data sent to the Sponsor concerning subjects or their participation in this 
study will be considered confidential according to HIPAA regulations.  Data used in the analysis 
and reporting of this evaluation will be used in a manner without identifiable reference to the 
subject.     
11.9.2 Amending the Investigational Study Protocol 
Only the study Sponsor can amend the Investigational Protocol.  All changes to the 
Investigational Protocol must be submitted to the IRB for review and approval.  Any change that 
would require alteration to the ICF must receive approval from the applicable IRB prior to 
implementation.  Following approval, any Investigational Protocol amendment must be 
distributed to all protocol recipients at the site. 
11.9.3 Protocol Deviations 
A protocol deviation is an unplanned excursion from the protocol that is not implemented or 
intended as a systematic change.  If an investigator failed to perform tests or examinations as 
required by the protocol or there were failures on the part of study subjects to complete 
scheduled visits as required by the protocol, would be considered protocol deviations. These 
types of deviations are reported to the sponsor and in accordance with the IRB policy. 
A Protocol Deviation CRF must be completed by the site for each study protocol deviation (e.g., 
failure to obtain informed consent, enrolling a subject who does not meet inclusion / exclusion 
criteria, not performing required testing, missed follow-up window, etc.).  An Investigator must 
notify the Sponsor and the reviewing IRB of any deviation from the study protocol that was done 
to protect the life or physical well-being of a subject.  Such notice should be given as soon as 
possible, but no later than five (5) working days after the emergency occurred. 
11.9.4 Site Noncompliance and Nonperformance 
Repeat protocol deviations will be closely monitored.  If excessive deviations or a failure to 
reduce deviations are noted, the Sponsor reserves the right to suspend study enrollment at that 
site until a sufficient system is in place at the site to reduce further deviations.  
 
After a site completes all required approvals and training, a site initiation visit will be conducted 
as a final check of the site readiness.  If a site is not able to enroll its first subject 3 months after 
“Ready to Enroll” status, the Sponsor may elect to terminate the investigational site and allocate 
the slot to another candidate site.   
11.9.5 Device Accountability 
The UltraGuideCTR is an FDA 510k cleared device, will be purchased by the investigational 
sites for use in the study, and does not require device accountability tracking within the study. 
 
 

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12. STUDY MONITORING 
The study sponsor is responsible to ensure that proper monitoring of this investigation is 
conducted.  Appropriately trained personnel, appointed by the study sponsor, will perform 
monitoring.  Monitors will ensure that the investigation is conducted in accordance with:  
 
• 
The signed Investigator’s Agreement 
• 
The Investigational Plan  
• 
Appropriate laws and regulations  
• 
Any conditions of approval imposed by the reviewing IRB and/or other regulatory agencies 
 
The clinical study will be monitored using electronic central monitoring processes.  On-site 
monitoring may occur as needed.  The sponsor may choose to perform random inspections 
throughout the study as an element of quality assurance.  Investigators shall allow auditing of 
their clinical investigation procedures, if necessary. 
 
A study specific Monitoring Plan will be created and implemented to standardize monitoring 
activities across centers and to ensure human subject protection and verify data integrity.  The 
monitors shall receive study specific and SOP training prior to conducting any monitoring visits.  
Study monitors are selected based on their training, qualifications, and experience to monitor the 
progress of an investigation.  Study monitors may be Sponsor’s employees or representatives.  
All study monitors will be required to follow the Sponsor’s monitoring plan and monitoring 
standard operating procedures (SOPs).  
Study closure is defined as a specific date that is determined by study completion and/or 
regulatory requirements that have been satisfied per the study protocol and/or by decision of the 
Sponsor.  Study closure visits will be conducted via telephone call for all enrolling clinical sites 
to review record retention requirements with site personnel.   
 
 
 

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