Prospective Randomized Double Blind Clinical Trial to Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology for the Ureteroscopic Treatment of Nephrolithiasis
Phase: NA
Conditions: Nephrolithiasis
Sponsor: Vanderbilt University Medical Center

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
1 
Protocol Date: 7/26/2022 
 
 
 
 
 
 
 
 
PROSPECTIVE RANDOMIZED DOUBLE BLIND CLINICAL TRIAL 
TO COMPARE HOLMIUM LASER LITHOTRIPSY WITH AND WITHOUT 
MOSES LASER TECHNOLOGY FOR THE URETEROSCOPIC TREATMENT 
OF NEPHROLITHIASIS 
 
 
Principal investigator: Nicole Miller, M.D., Associate Professor 
VUMC Department of Urology 
A1302 Medical Center North 
1161 21st Avenue, South 
Nashville, TN  37232-2765 
 
 
 
Identifiers: 
 
 
NCT04505956    
Unique Protocol ID: 
 
Moses Ureteroscopy RCT 
Brief Title: 
A Comparison of Ureteroscopic Treatment of 
Nephrolithiasis With and Without Moses Technology 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
2 
Protocol Date: 7/26/2022 
 
 
 
 
 
 
 
 
 
 
Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Animal Studies and Previous Human Studies 
4.0 
Inclusion/Exclusion Criteria 
5.0 
Enrollment/Randomization 
6.0 
Study Procedures 
7.0 
Risks of Investigational Agents/Devices (side effects) 
8.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
9.0 
Study Withdrawal/Discontinuation 
10.0 Statistical Considerations 
11.0 Privacy/Confidentiality Issues 
12.0 Follow-up and Record Retention 
13.0 References

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
Background 
 
Flexible ureteroscopy is characterized as first-line therapy for renal stones < 2 
cm in size (1,2). Holmium: YAG laser remains the preferred energy modality to 
break stones of this size into fragments small enough to remove or pass 
spontaneously through the ureter (2). Advances in the understanding of laser 
energy delivery have led to the recent commercialization of the “Moses Effect” – 
the creation of vapor bubbles/cavities between the laser fiber tip and the target 
through which laser energy can more efficiently travel (3). Lumenis was the first 
to optimize this laser phenomenon and market it as “Moses Technology” in their 
Lumenis PulseTM P120H laser system.  
 
There is ongoing debate on the optimal means of laser stone fragmentation, and 
Moses technology is the latest advancement to raise questions regarding clinical 
utility. To date, there are limited clinical data obtained through rigorous study 
methodology. In addition, knowledge gaps remain regarding the effect of Moses 
technology on other clinically meaningful outcomes such as stone-free rate.  
 
Therefore, we propose a multi-center, prospective, randomized, double blind 
clinical trial to further assess the effect of Moses technology for lithotripsy. We 
aim to study a broader range of outcomes which will be facilitated by being the 
largest study to date. We also aim to study novel outcomes such as grading 
retropulsion and visibility by independent blinded review as well as effects of 
Moses technology on reducing surgeon perceived workload using the NASA Task 
Load Index (NASA-TLX)(4,5).  
 
1.0 
Rationale and Specific Aims 
 
The purpose of this study is to evaluate the potential of Moses laser technology 
to reduce operative time compared to non-Moses settings for ureteroscopic 
treatment of nephrolithiasis.  
 
Our primary objective is to compare total operative times between Moses 
holmium laser lithotripsy and non-Moses holmium laser lithotripsy in the 
ureteroscopic treatment of renal stones using a dusting technique. Our 
secondary objective is to evaluate Moses technology to reduce stone retropulsion 
during holmium laser stone fragmentation.  
 
We hypothesize that the Moses laser technology will significantly decrease total 
operative time for treatment of renal stone burden totaling 8-20 mm in diameter. 
 
2.0 
Animal Studies and Previous Human Studies 
 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
Initial preclinical studies by Sero Andonian’s group demonstrated significantly 
reduced stone retropulsion and higher stone ablation volume with Moses 
technology, leading to the conclusion that the system allows more efficient laser 
lithotripsy (6). Further work by this group using a stone simulator supported 
these findings. There was decreased retropulsion and decreased procedure 
duration in both the dusting and fragmentation models. In the fragmentation 
model, the decrease in procedural time was approximately 35% (13.9 min versus 
9.1 min) (7).  
 
Initial human studies by Mullerad et al. also showed that laser lithotripsy with 
Moses technology utilized laser energy in less time for stone fragmentation: 10.0 
(2.6-15.0) min vs 6.0 (2.8-13.0) min (8). 
 
Nonetheless, not all measures of outcomes have been supportive. Stern and 
Monga evaluated the cost effectiveness of Moses technology in their own cohort 
of 40 patients who underwent standard laser lithotripsy by comparing the 
savings achieved from a 35% projected decrease in procedure time against the 
cost of the Moses laser fiber and machine. Mean stone size was 10.2 mm in this 
group of patients, and mean lasing time was 3.0 minutes. While a significant 
positive association was seen between stone size and laser time, cost analysis 
failed to show a benefit in using Moses technology across sizes (9).  
 
A randomized, double blind clinical trial evaluating Moses technology in 66 
patients undergoing ureteroscopy was presented as a 2018 European Association 
of Urology abstract. While this single center study demonstrated safety and 
reduced fragmentation time as well as procedure time using Moses technology, it 
did not show a significant difference in stone-free rates (10). Their study is yet to 
be published as a manuscript. 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 
• Solitary renal stone 8 to 20 mm in size or in the case of multiple stones 
the conglomerate diameter (additive maximal diameter of all stones on 
axial imaging of computed tomography) of 8-20 mm is required  
• Must be a suitable operative candidate for flexible ureteroscopy per 
urologic guidelines (1) 
• Must be 18 years or older 
• Must be able to give consent 
 
Exclusion criteria: 
• Concomitant stones in the ureter 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
• Prior ipsilateral upper urinary tract reconstructive procedures or history of 
ipsilateral ureteral stricture 
• Prior radiotherapy to the abdomen or pelvis 
• Neurogenic bladder or spinal cord injury 
• Pregnancy 
• Untreated UTI 
 
Attending surgeons participating in the study at must be urological surgeons 
specializing in kidney stones.  
 
4.0 
Enrollment/Randomization 
 
The trial will be a prospective, randomized, double blind study of patients with 
renal stones 8-20 mm in size located at or above the level of the ureteropelvic 
junction. This is a multi-institutional study and will collaborate with the Cleveland 
Clinic, Columbia University, Duke University, University of California San Diego, 
Indiana University, and Mayo Clinic (Arizona) using an identical protocol. Total 
enrollment will be limited to 300 patients for the study with each site having a 
goal of up to 100 patients, understanding that some sites may recruit less than 
their goal. Each site is responsible for its own IRB approval. Ureteroscopic 
treatment of renal calculi is a standard of care treatment approach, and in the 
course of participating in this study no treatments will be performed that are not 
considered standard of care. 
 
Patients will be identified based on clinic visits or hospital admission.  
 
Patients will be randomized on a 1:1 basis to standard holmium laser lithotripsy 
dusting settings or holmium laser lithotripsy using Moses technology. All 
surgeons will be blinded to the randomization and only the laser technician will 
know the randomization. The randomization will be stratified by centers and also 
by renal stone size (8.0-12.0mm, 12.1-16.0mm, 16.1-20.0mm). Block sizes of 2, 
4, and 6 will be used within each stratum to enhance blinding. The 
randomization system will be developed using R, implemented using RedCap and 
maintained in the Center for Quantitative Sciences server at Vanderbilt.  
 
5.0 
Study Procedures 
 
Procedures performed in this study that are standard of care: 
 
Patients will be identified based on clinic visits or hospital admission. All patients 
will be counseled on standard treatment options – extracorporeal shock wave 
lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and ureteroscopy 
(URS). The discussion regarding treatment options and subsequent care will not 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
deviate from routine care. Those selecting URS will be enrolled to have data 
collected prospectively. Patients will be consented prior to surgery for collection 
of demographic, disease, perioperative, and postoperative data. Abdominopelvic 
computed tomography (CT) will be used to delineate pre-operative stone size, 
with measurements captured in greatest axial and coronal dimensions. A 
preoperative abdominopelvic CT will be obtained if one is not available as 
clinically indicated per urologic guidelines (1). 
 
Patients will have flexible URS performed in standard fashion, without deviation 
from the standard of care. The patient will be brought to the operating room and 
given general or regional anesthesia per anesthesia and patient preference. The 
patient will be placed in lithotomy position and prepared and draped in standard 
fashion. Rigid cystoscopy will be performed and a flexible guidewire will be 
placed through the ipsilateral ureter to the kidney under fluoroscopic guidance. A 
second wire will be placed at the discretion of the surgeon. Ureteral dilation will 
be performed at the discretion of the surgeon. A ureteral access sheath will be 
used at the discretion of the surgeon. Flexible URS and holmium laser lithotripsy 
will be performed using a dusting technique for stone fragmentation. For all 
patients, a Moses laser fiber will be utilized.  
 
Laser settings will be at the surgeons’ discretion but will be within the range 
identified as standard for dusting technique (between 0.2-0.5 J and 40-120 Hz). 
Moses laser technology will be utilized in distance mode as allowed by the 
machine when frequency is less than 80 Hz. The short pulse setting will be 
utilized for non-Moses settings. A representative stone fragment will be removed 
and sent for stone analysis. An additional fragment may be sent for culture at 
the discretion of the surgeon. Adequacy of dusting will be defined as stone 
fragments smaller than the laser fiber diameter. A ureteral stent will be placed at 
the conclusion of the surgery. A string will be left on the stent at the discretion of 
the surgeon. Post-operative medical therapy will be an alpha receptor blocker to 
induce ureteral relaxation if not contraindicated for allergy, cataracts, or history 
of adverse reaction. Additionally, standard postoperative pain medications will be 
prescribed at the discretion of the treating surgeon. 
 
The stent will be maintained for 4 to 10 days after surgery. Imaging studies will 
be performed at 6 weeks postoperatively; post-operative imaging will be a CT 
abdomen/pelvis (low dose where available) to assess for stone-free rate, 
development or persistence of hydronephrosis/obstruction, and need for ancillary 
procedures.  
 
Procedures performed in this study that are specific to research: 
 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
Attending surgeons will complete a survey at the end of the procedure to confirm 
their blindedness and predict whether Moses settings were utilized. The survey 
will also include the NASA-TLX to measure surgeon workload (11). The principal 
and sub-investigators (attending surgeons) completing the survey will not have 
access to individual survey responses prior to data analysis. 
 
Representative video clips of stone dusting will be obtained for blinded video 
review. All other procedures in this study are performed per standard of care. 
 
Data points: 
 
Demographic fields that will be obtained preoperatively include age, race, 
gender, ASA (American Society of Anesthesiologists) score (for comorbidity 
assessment), height, weight, body mass index (BMI), and prior stone disease. 
Disease fields that will be obtained include stone size (maximal axial and coronal 
dimensions), degree of hydronephrosis (mild/moderate/severe), and prior 
ureteral stenting or nephrostomy tube placement.  
 
Perioperative fields will include total operative time, procedure time, laser time, 
laser fiber size, settings of lithotripsy (rate, energy), total laser energy used, 
anesthesia time, type of anesthesia, use of active fragment extraction (beyond 
that for analysis/culture), 1st assist skill level, use of ureteral access sheath, 
intra-operative complications, and treatment on any anticoagulation.  
 
Postoperative fields will include length of hospitalization, postoperative 
complications, stone composition, need for ancillary procedures, stent duration, 
and stone-free status on postoperative CT imaging. 
 
The degree of intra-procedure stone retropulsion and visibility will be assessed 
using a Likert scale by blinded video review consisting of 3 individuals. Adequacy 
of dusting will be graded as a binary variable. Video clips comprising the first 20 
seconds and the last 20 seconds of dusting should be recorded. Blinded 
reviewers will be surgeons who specialize in ureteroscopy and are not employed 
by a study center.  
 
6.0 
Risks 
 
The risks of participating in the study are the same as that of ureteroscopy 
offered as standard of care. These risks include pain, bleeding, infection, trauma 
to the urinary tract, and stricture development. Infection may be severe and life 
threatening in the form of sepsis requiring ICU hospitalization. Trauma to the 
urinary tract and/or stricture development may be severe and require future 
procedures. Loss of renal function may be seen as a result of trauma to the 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
urinary tract, stricture development and any consequent procedures. There may 
be unknown or unanticipated adverse effects. 
 
7.0 
Reporting of Adverse Events or Unanticipated Problems involving 
Risk to Participants or Others 
 
Adverse events will be monitored for by key study personnel at VUMC from both 
patient reported data and review of electronic medical records for phone calls, 
emergency room visits, hospital admissions, re-operations and clinical visit notes. 
 
The principal investigator and/or research team member will report any adverse 
event to the IRB within 7 days of awareness. A data monitoring committee will 
not be used. Participant safety will be protected by standard of care for the 
surgical procedure which includes post-discharge follow-up in clinic 6 weeks after 
the procedure and a non-contrast CT abdomen/pelvis. The principal investigator 
and other key study personnel will monitor any unanticipated problems during 
the standard of care follow-up period and assess all safety and efficacy data. 
 
Regarding other institutions involved in the study, each institution will be 
required to monitor for adverse events and report to their individual IRBs as well 
as VUMC at the same time. VUMC will then inform other participating cites of the 
serious adverse event or unanticipated problem via email communication 
immediately. These communications will be de-identified to protect individual 
patient information at a specific site. It is the responsibility of each individual 
study site to report the event or problem to their respective IRB as well as assess 
for similar adverse events or unanticipated problems. 
 
8.0 
Study Withdrawal/Discontinuation 
 
Subjects would be withdrawn from the study if their anatomy complicates the 
assigned laser settings or intraoperatively, access is unobtainable in a retrograde 
fashion. Additionally, participants will be withdrawn if staged ureteroscopy is 
deemed necessary intraoperatively (>1 ureteroscopy for the treatment of the 
ipsilateral stone burden). Subjects may withdraw from the study at any time. 
 
9.0 
Statistical Considerations 
 
Power: 
 
Hypothesizing a 6 minute decrease in total operative time for the Moses laser 
group, a sample size of 146 patients per group across all sites will have 80% 
power to detect a 20% decrease in the total procedure time. If a 5% dropout 
rate is assumed, the total sample size will be 300 patients. Mean operative time 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
for dusting using non-Moses settings was estimated as 35.9 minutes +/- 17.8 
min based on results from a previous dusting trial (12). 
 
Data Management: 
 
The electronic data will be stored in the REDCap (Research Electronic Data 
Capture) application (13,14). REDCap is a stand-alone system with no interaction 
or connectivity to other systems, and the database is located behind the VUMC 
firewall. Users must have a VUMC provided ID/password to connect to REDCap 
and their ID must be specifically authorized in order to access an individual 
study's data. All changes to the data, and each "record viewed" is logged back to 
the individual ID with a timestamp. When the case report forms are configured, 
each field has an attribute that can be set to flag it as an “identifier”. This 
“identifier” is used by REDCap to control certain actions related to the field. 
REDCap also has several built-in functions to control the exporting of identifying 
information. Individual users are each granted specific export rights, including – 
None, De-Identified, and Full. Additional export de-identification options include 
removing identifiers and dates, hashing IDs and date shifting. Centers will be put 
into Data Access Groups so that they only have access to their own data and not 
that of other sites. The data center (VUMC) will be the only center will access to 
the full dataset. 
 
Statistical Analysis: 
 
Intention-to-treat analysis will include all randomized subjects. Demographic data 
and pre-operative and post-operative data for each treatment group will be 
summarized using median and quartiles (continuous variables) and frequency 
and percent (categorical variable). Baseline data will not be compared across 
treatments as this is a randomized study.  
 
The primary outcome is total operative time, and it is assumed to have a strong 
correlation with the stone size. A linear regression model will be fit with total 
operative time as the response variable and the treatment (Moses vs non-Moses) 
and stone size as the main covariates. An interaction term between the 
treatment and total operative time will be included in the model to allow for 
treatment effect estimation at a specific value of stone size. Using this model, we 
will be able to estimate the difference in total operative time with a 95% 
confidence interval at a given stone size and if the treatment effect is uniform 
across stone size. Statistically significant treatment effect on the primary 
outcome is required to conclude treatment effect. 
  
The secondary outcomes (stone retropulsion and visibility) will be analyzed with 
the same regression model. Factorial ANOVA will be used to determine any 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
interaction between Moses utilization and stone size on workload as measured by 
NASA-TLX. Surgeon prediction of Moses utilization will be compared to the actual 
setting using chi-squared tests. Stone free rates and complications will be 
compared using Fisher’s exact test. Odds ratios and a 95% confidence interval 
will be used to quantify treatment-effect difference on these endpoints.  
 
An interim analysis will be performed using a group sequential design to assess if 
the study can be stopped early. This will be performed at enrollment milestones 
of n=150 and n=230. 
 
10.0 Privacy/Confidentiality Issues 
 
Data will be collected and stored within REDCap (Research Electronic Data 
Capture). Only key study personal listed as the principal investigator, study 
coordinator and research-clinical roles will have access to the research 
information and video recordings. The principal investigator and study 
coordinator will have access to the medical record numbers and unique study 
identification numbers for each participant. Only the study coordinator and 
research-clinical roles will have access to the surgeon survey responses; the 
principal investigator and those listed as sub-investigators will not have access to 
this data prior to data analysis. Video recordings will be de-identified when 
stored in an encrypted drive and will be accessible only by key study personnel. 
De-identified video recordings will be sent to blinded reviewers using Secure File 
Transfer services. 
 
Consent forms will be secured in a study binder and stored in a locked office. 
Responses to surgeon questionnaires will be annotated into REDCap and stored 
in a study binder which will be located in a locked office. At the completion of the 
study, all contents within the study binder including consents and questionnaires 
will be destroyed in a secure fashion per hospital policy for HIPAA compliance. 
 
Recorded video will include only intracorporeal image frames of the renal pelvis. 
There will be no patient identifying information in the video clips such as external 
anatomy/features, PHI, date of surgery, etc. Recorded video clips will only be 
labeled by the participants' unique study ID number and blinded reviewers 
outside of VUMC will only have that label for identification. 
 
11.0 Follow-up and Record Retention 
 
Each patient in the study will be followed for 6 weeks after the operation. It is 
anticipated the data collection will take 30 months to complete, and another 12 
months to analyze the data. The principal investigator will maintain the 
information indefinitely in a password protected, encrypted database. All 

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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Protocol Date: 7/26/2022 
identifiers will be destroyed 4 years after the study initiation, or 2 years after 
data collection is complete, whichever is sooner. Video will be destroyed upon 
completion of data analysis except for select de-identified clips to be used for 
study presentation purposes. 
 
13.0 References 
 
1.  
Assimos Dean, Krambeck Amy, Miller Nicole L., Monga Manoj, Murad M. Hassan, 
Nelson Caleb P., et al. Surgical Management of Stones: American Urological 
Association/Endourological Society Guideline, PART II. Journal of Urology. 2016 Oct 
1;196(4):1161–9.  
2.  
Türk C, Petřík A, Sarica K, Seitz C, Skolarikos A, Straub M, et al. EAU Guidelines on 
Interventional Treatment for Urolithiasis. European Urology. 2016 Mar 
1;69(3):475–82.  
3.  
Ventimiglia E, Traxer O. What Is Moses Effect: A Historical Perspective. Journal of 
Endourology. 2019 Mar 20;33(5):353–7.  
4.  
Law KE, Lowndes BR, Kelley SR, Blocker RC, Larson DW, Hallbeck MS, et al. NASA-
Task Load Index Differentiates Surgical Approach: Opportunities for Improvement 
in Colon and Rectal Surgery. Annals of Surgery. 2018 Dec;1.  
5.  
Dias RD, Ngo-Howard MC, Boskovski MT, Zenati MA, Yule SJ. Systematic review of 
measurement tools to assess surgeons’ intraoperative cognitive workload. Br J 
Surg. 2018 Apr;105(5):491–501.  
6.  
Elhilali MM, Badaan S, Ibrahim A, Andonian S. Use of the Moses Technology to 
Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. J Endourol. 
2017 Jun 1;31(6):598–604.  
7.  
Ibrahim A, Badaan S, Elhilali MM, Andonian S. Moses technology in a stone 
simulator. Can Urol Assoc J. 2018 Apr;12(4):127–30.  
8.  
Mullerad M, Aguinaga JRA, Aro T, Kastin A, Goldin O, Kravtsov A, et al. Initial 
Clinical Experience with a Modulated Holmium Laser Pulse—Moses Technology: 
Does It Enhance Laser Lithotripsy Efficacy? Rambam Maimonides Med J [Internet]. 
2017 Oct 16 [cited 2019 Oct 25];8(4). Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5652929/ 
9.  
Stern KL, Monga M. The Moses holmium system - time is money. Can J Urol. 
2018;25(3):9313–6.  
10.  Ibrahim A, Fahmy N, Carrier S, Elhilali M, Andonian S. 990 - Double-blinded 
prospective randomized clinical trial comparing regular and moses modes of 
holmium laser lithotripsy: Preliminary results. European Urology Supplements. 2018 
Mar 1;17(2):e1390.  

Vanderbilt University Medical Center  
Department of Urologic Surgery  
A-1302 Medical Center North  
Nashville, TN 37232-2765 
Protocol Version #: 7 
 
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11.  Hart SG, Staveland LE. Development of NASA-TLX (Task Load Index): Results of 
Empirical and Theoretical Research. In: Advances in Psychology [Internet]. 
Elsevier; 1988 [cited 2019 Dec 16]. p. 139–83. Available from: 
https://linkinghub.elsevier.com/retrieve/pii/S0166411508623869 
12.  Humphreys Mitchell R., Shah Ojas D., Monga Manoj, Chang Yu-Hui, Krambeck Amy 
E., Sur Roger L., et al. Dusting versus Basketing during Ureteroscopy–Which 
Technique is More Efficacious? A Prospective Multicenter Trial from the EDGE 
Research Consortium. Journal of Urology. 2018 May 1;199(5):1272–6.  
13.  Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic 
data capture (REDCap)—A metadata-driven methodology and workflow process for 
providing translational research informatics support. Journal of Biomedical 
Informatics. 2009 Apr;42(2):377–81.  
14.  Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap 
consortium: Building an international community of software platform partners. 
Journal of Biomedical Informatics. 2019 Jul;95:103208.