Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment Study
Phase: NA
Conditions: Short Bowel Syndrome
Sponsor: University of Michigan

 
 
 
 
Michigan ENdoluminal Distraction Device 
(MENDD) Tolerance Assessment Study 
NCT06185088 
IRB Approval Date: October 4, 2023 
 
 

 
Protocol Number: HUM 
Title: Michigan ENdoluminal Distraction Device (MENDD) Tolerance Assessment 
Study 
 
National Clinical Trial (NCT) Identified Number:  n/a 
Principal Investigator: Meghan Arnold 
Funded by: Internally Funded 
Version Number:  v.1.1 
6-28-23 
 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
7/7/23 
Initial approved version  
 
6/28/23 
Change PI from Ralls to Arnold 
Ralls leaving institution  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
1.0 
Protocol Summary/Synopsis  
 
Title: 
Michigan ENdoluminal Distraction Device (MENDD) Tolerance 
Assessment Study 
 
Study Description: 
We hypothesize the radial and longitudinal forces necessary to 
produce enterogenesis will cause low levels of discomfort in 
healthy adult patients.  Approved devices will be utilized in an 
off-label manner to reproduce forces similar to our novel 
medical device which is designed to treat short bowel 
syndrome.   
  
Objectives: 
 
The primary objective is to assess the discomfort level caused 
by balloon deployment (radial stretch) within the intestinal 
lumen in awake patients. Secondary objectives include 
assessment of the discomfort level caused by producing short 
term longitudinal stress on the intestinal lumen.   
 
Endpoints: 
Primary Endpoint: Completion of a pain rating scale during 
radial stretch.  If tolerable pain thresholds are met, subjects will 
move on to the secondary objectives. 
 
Secondary Endpoints: Completion of a pain rating scale while 
enduring longitudinal stress on the small bowel. 
 
Study Population: 
Five otherwise healthy adult patients with small bowel stomas 
undergoing routine procedures at the University of Michigan 
will be recruited   
 
Phase: 
 
Early Feasibility 
 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
 
All individuals will be enrolled at Michigan Medicine.  
 
 
Description of 
Study Intervention: 
 
The Michigan ENdoluminal Distraction Device (MENDD) 
centers around the well-known principle of mechano-
transduction. This is defined as the conversion of mechanical 
stimuli to biochemical signals that elicit specific cellular 
response. In this case, intraluminal, longitudinal tensile forces 
result in intestinal growth and lengthening (enterogenesis). 
This study will utilize approved devices in an off-label manner 
to create forces required to induce intestinal lengthening. 

 
Radial and longitudinal forces are both required, and two 
devices will be used to create forces in order to test tolerability 
of a said forces. This is to provide evidence that humans could 
tolerate the forces produced by a proposed commercially built 
device.  
 
Study Duration: 
6-12 months 
 
Participant 
Duration: 
Subjects will be in the study for 15-60 minutes on the day of 
procedure and monitored per normal recovery under nursing 
care from their scheduled procedure.  Phone interviews will 
take place at 30 days post procedure to monitor for adverse 
events.  
 
 
 
 
2.0 
Introduction 
2.1 
Study Rationale 
Short-bowel syndrome (SBS) is found in children who undergo massive 
intestinal resection for several congenital or acquired conditions resulting 
in insufficient intestinal length to sustain life. These patients require IV 
nutrition and hydration (parenteral nutrition, PN) for adequate growth and 
development1. PN requires invasive surgery for placement of central 
catheters, and often a tethering for 24 hours a day to an IV pump. SBS 
patients and their families spend most of their time in a hospital. Further, 
these children are susceptible to complications of their underlying disease 
processes, as well as to PN use including electrolyte disturbances, 
dislodgment or infection of the central catheter and liver failure. Accurate 
estimates of incidence and prevalence of SBS are difficult for many 
reasons; however, a survey of Pediatric Intestinal Failure Consortium 
(PIFCON) centers resulted in an incidence of 1,650 pediatric SBS 
patients. Approximately 50-55% of these patients either do not survive 
beyond the first month of SBS diagnosis, or rapidly wean off of PN and 
therefore would not be included in our target patient population. Based on 
this line of rationale, it is estimated that the overall incidence of pediatric 
SBS is ≈700/year adding to the existing 10,000 to 20,000 patients who 
require home PN in the U.S.   
Caring for a SBS patients is costly. Best estimates put the cost of care for 
each SBS patient at over half a million U.S. dollars in the first year post-
diagnosis, and $300,000 each year after2. Current treatments to alleviate 
SBS are high risk, expensive, and have varied results. The growth 
hormone Teduglutide®, a GLP-2 analogue, stimulates bowel growth and 
function3. Currently use is limited to adults and the adaptive process may 
reverse after drug termination4. Additional concerns with GLP-2 include a 
very high cost (≈$300,000/year) and a significant cause for concern for 
development of GI malignancies with prolonged use5.  Surgical 
lengthening is another option6. These procedures require a laparotomy 
and long hospital stay. The operation carries a potential risk of injury to 
the bowel, intestinal vasculature, leakage of enteric contents, and can only 
be done if the intestine is overly dilated. Moreover, it is also associated 
with up to a -60% failure rate7,8. Finally, small bowel transplantation has 

 
been used when other treatments fail. Although a viable option, 
transplantation is expensive (>$450,000/pt.)9, requires long-term 
immunosuppression, and carries the risks of infection and graft failure. 
While early patient and graft survival are good, 3-year survival is ≈60%10.  
 
Short bowel syndrome is problematic not only for the patient, but also the 
family and the healthcare system with little hope of cure. Thus, there 
remains a great need for an alternative procedure to treat SBS that 
will lower cost, have higher success rate and lead to greater quality 
of life. Our 20 years of research and development have led to the point 
where we have a nonoperative strategy to increase intestinal length in an 
animal model. We need to ensure the forces created by the device are 
tolerable to humans.  While there is no evidence of pain in the numerous 
animal models, human data is essential.  Healthy adults afford us the 
opportunity to discuss the sensations created by bowel distension (albeit 
minimal) and longitudinal stress on the small bowel. The MENDD team 
consider these data critical to pursue the costly endeavor of building a 
device fit for human testing based on our animal prototype created at the 
university of Michigan mechanical engineering labs of Drs. Diann Brei and 
Jon Luntz.  
 
 
2.2 
Background 
MENDD therapy comprises the progressive application of distractive 
forces to the small intestine to induce cellular proliferation, also known as 
mechanotransduction-induced growth. This is a concept that has been 
used in numerous clinical applications for over 100 years, including limb-
length discrepancy, tissue expanders, and dental braces.  Confirmation of 
these mechanisms of growth for bowel tissue has been recently 
demonstrated in rodent11, rabbit12, and porcine models13,14,15, all using pre-
clinical methods of applying distractive forces.  In our own key study, a 
pre-clinical hydraulic device induced significant bowel growth in pigs and 
re-implantation of the lengthened intestine into the normal continuity of 
enteric flow preserved bowel length as well as absorptive and peristaltic 
function. This demonstrates the viability of the mechanotransduction 
approach for growth in bowel16. In another study, a non-clinical iteration 
device was placed in a Roux-en-Y jejunal segment.  In a 6-pig trial, 
distracted segment lengths increased 67±15% corresponding to 
12.9±5.6cm gain (1.0-1.2cm/day), vs. minimal growth in fed, non-
distracted bowel. Moreover, the distracted segment showed an increased 
epithelial cell proliferation (by PCNA staining) vs. control as further 
evidence of true growth.  MENDD therapy results of 67% growth is a 
significant increase over current surgical lengthening procedures, where 
a mean gain of 37 and 47% has been reported17,18. Distracted segments 
show thicker smooth muscle, increased villus height, increased crypt 
depth and restored segments after distraction demonstrated equal water 
absorption and greater glucose absorption19.  Though these study and 
others demonstrate the great potential for MENDD therapy, none of the 
devices utilized in these studies are directly clinically applicable for 
humans.   
Our current MENDD prototype is dual catheter-based device with a 

 
proprietary attachment on both an inner and outer catheter (Figure 1).  
Once the intraluminal attachments are engaged, the inner catheter is 
advanced increasing the inter-attachment distance thus providing 
longitudinal tension on the intervening segment of intestine. This most 
recent prototype can produce the necessary forces to induce growth, but 
the tolerability of the device is unknown. This study will answer the 
question if forces required to induce growth are tolerable to awake humans 
and will be accomplished by using approved devices to reproduce the 
forces generated by MENDD. This will provide confidence in the 
investigators, the university, regulatory bodies, as well as in funding 
sources of the potential MENDD device. With completion of this study, we 
will proceed with commercial manufacturing of the device under design 
controls and specifications with the eventual goal of applying for an IDE in 
order to place the MENDD device into humans.      
 
 
2.3 
Risk Benefit Assessment 
2.3.1 Known Potential Risk 
Immediate risks include intraoperative complication.  These are similar to 
any endoscopic procedure and are rare.  The deployment of a ballooned 
catheter in the intestinal lumen is common practice.  However, in this 
study, a balloon designed for intravascular deployment will be used.  This 
is because the balloon characteristics are most like that of our future 
device. With intraluminal balloon deployment, risks include damage to the 
bowel wall and perforation.  This is very rare, and risk will be mitigated by 
the known dimensions of the balloon and other balloon characteristics. 
Further, this will be done in healthy bowel. Balloon dilation is typically done 
for diseased bowel that is at higher risk of damage.  
Long term risks could result from in intraoperative complication including 
the need to repair any damage to the intestinal tract. This could result in 
unplanned hospitalization which in turn could have psychological, social, 
legal, and economic consequences.  
The MENDD design is unique, and no other procedure can be performed 
to gather the necessary data. Numerous animal models have been 
completed and have not demonstrated pain, but human data is required.  
 
2.3.2 Known Potential Benefits 
The benefits of this study are purely societal. Individuals would be helping 
make a case for continuation of device development with the aims of 
helping short bowel patients in the future.   
 
2.3.3 Assessment of potential risk to benefit   
Participants enrolled in this study will gain no benefit other than providing 
information that may lead to lessen the hardship of others through device 
development. Children with short bowel syndrome live an exceedingly 
difficult life that stresses not only the patient, but also the family and the 
healthcare system. Any innovation to treat short bowel syndrome could 
save thousands of hospitalizations and millions of dollars. The risk to 
individuals is possible damage to intestine ranging from minor mucosal 
damage to frank perforation.  Our understanding of intestine as well as 
balloon mechanics has led us to choose devices that we feel carry a low 

 
risk profile yet will reproduce the forces created by MENDD.   
In the first step, The Coda® balloon is specially constructed to radially 
expand with a known diameter dependent on the fill volume (figure 2). This 
device is approved for intravascular use within the aorta and other major 
vessels where precision and accuracy are of the utmost accuracy and are 
of the utmost importance. Further, the FDA has approved balloon devices 
made of similar material for use in the bowel with a diameter of 40mm or 
larger. Not only are these sizes FDA approved, but intended for use in 
narrowed, diseased bowel. The difference in these GI specific balloons is 
that they are quite long and do not match the MENDD specifications. 
Moreover, these balloons will only be inflated on the order of minutes. The 
purpose of this study is to evaluate the sensation of discomfort generated 
by intraluminal inflation of the balloons and respond to the survey. The risk 
of damage to the participants’ intestine is very low.  The study is designed 
to have an awake patient so any pain will alert the staff to deflate the 
balloon if the subject expresses severpain.  
The second step of the study comprises the placement of a double balloon 
enteroscope (DBE) retrograde into a stoma (Figure 3). This device is 
approved for use by advanced endoscopists and carries a low risk profile. 
A Gastroenterologist with expertise with this device has been involved in 
planning of this study as well as will be performing the portion of the study 
requiring the DBE. The device has numerous risk mitigation features listed 
in the appendix of this protocol. In short, the balloons are pressure 
regulated to not cause damage to the bowel. These sensors also alarm if 
undue tension is placed on the intestine. We will be able to monitor those 
alarms as well as the response from study subjects for discomfort. The 
risk of intestinal damage is low. The DBE itself is 9.4mm at its largest point 
which should pass through the stoma without complication. However, 
should an individual have a minor narrowing of the fascial defect through 
which the stoma is matured, there may be some discomfort and minor 
trauma to the intestinal mucosa. This may cause the termination of the 
subject’s participation in the study but would not be considered a failure to 
meet the endpoints.    
 
3.0 
Objectives and Endpoints 
The primary objective is to assess the discomfort level in awake patients 
with radial distension of the intestine to a known diameter. This will be 
accomplished with deployment of a balloon with similar characteristics to 
a proposed medical device. The secondary objective is to place 
longitudinal forces on intestine using a DBE and asses the discomfort 
level. 
Longitudinal 
tension 
is 
necessary 
to 
create 
the 
mechanotransductive forces necessary to induce intestinal growth. 
However, in this current study, the forces will not be of the duration to 
induce growth. These studies serve as precursor studies to obtain data on 
the tolerability of forces placed on bowel during proposed MENDD 
therapy. Future studies would include placement of a MENDD prototype 
device in healthy adult volunteers with ileostomies with the objectives to 
include 1) to demonstrate feasibility of endoscopic placement of MENDD 
via an existing stoma and 2) to demonstrate no serious adverse events 
with actuation of the device while in human intestine.   
Discomfort levels will be assessed through an interview process 

 
performed by the study team members during the procedures described. 
Simple validated pain scales and surveys will be used (Figure ). The 
observation period of the study will end either with conclusion of the 
questionnaire of discomfort described as too great to continue.  
 
 
4.0 
Study Design 
4.1 
Overall Design  
Our team posits intraluminal forces placed on the intestine required to 
produce distraction eneterogenesis are tolerable in awake individuals. 
This early feasibility study serves as a bridge from preclinical animal 
studies that have demonstrated pain free intestinal lengthening. The 
purpose is to demonstrate that our proposed clinical device will not cause 
discomfort so great in humans that the procedure will require sedation. 
FDA approved devices will be used in an off-label manner to reproduce 
the forces required to induce intestinal growth in an acute setting. Because 
this is simply a study to test the tolerance of the forces required, the goal 
is not to produce any bowel lengthening during this procedure.   
The trial to be conducted is adaptive - completion of all endpoints will be 
dependent upon completion of previous endpoint. Adult subjects will be 
approached based on a medical condition of having an ileostomy. Age, 
gender, race, or any other identifying factor will not be considered in 
recruitment at this single site study.      
 
4.2 
Scientific Rationale for Study Design 
This early feasibility study will answer a simple question of whether the 
forces required to induce intestinal growth cause pain in humans. Two 
distinct forces will be tested. First, radial stretch of the intestine to a known 
diameter will be tested. Should the individual tolerate the radial stretch, 
the subject will move to the second step of the study. A second device will 
be used to create longitudinal stress on the intestine, the second force 
required. Two approved devices are necessary due to the unique 
characteristics of each device. Radial stretch will be tested with a balloon 
with a known diameter maximum used in intra vascular procedures. This 
is a similar diameter to our future device. Larger balloons are approved for 
intestinal use, suggesting this balloon deployment will have little effect on 
the physiology and sensation of the intestine. However, we aim to 
understand the interaction of the intestine with balloons that are 
comparable to our device.   
If the subject tolerates the radial stretch, a DBE will be used to generate 
acute longitudinal tension. The proposed MENDD will be able to create 
longitudinal stress over periods of minutes to hours while the DBE can 
create this tension over seconds to minutes. The balloon characteristics 
on the DBE are far different from the MENDD balloons and thus cannot be 
used for the first step in the study.   
4.3 
End of Study Definition 
A participant is considered to have completed the study if he or she has 
completed all phases of the study including a 30 day follow up phone 
interview or the last scheduled procedure. 
 
5.0 
Selection of Patients 

 
5.1 Inclusion Criteria (list):  
• 
Adults 18 - 80  
• 
Existing Ileostomy older than 6 weeks 
• 
Undergoing any existing procedure in endoscopy suite or 
operating room. 
 
5.2 
Exclusion Criteria (list):  
• 
Inflammatory bowel disease of small bowel 
• 
Pregnant 
• 
Short bowel syndrome 
• 
Bleeding disorder 
• 
Chronic pain disorder 
• 
Individuals taking chronic pain medications including 
prescriptions, cannabinoids or over the counter. 
• 
Individuals taking pain medications at the time of the procedure 
• 
Cognitive Impairment to the extent that the questionnaire cannot 
be completed  
 
5.3 
Strategies for Recruitment 
The study team will work directly with the PI and the departmental 
scheduler to identify subjects scheduled for any case meeting the 
criteria. We are aiming to recruit subjects already undergoing a minor 
procedure for routine health screening or other health matters, thus, 
avoiding any unnecessary procedures for subjects. Rather, we intend to 
approach participants undergoing the procedure as standard of care and 
will add on the study intervention(s).  
 
Compensation will be offered to participants who complete study 
activities. Participants who complete the initial screening and procedure 
will receive a $100 gift card and an additional $100 gift card once the 
follow up phone call is completed to assess for adverse events.  
 
6.0 
Study Intervention 
6.1 
Study Intervention Administration  
In this study, we will use two FDA approved devices in an off-label manner 
to replicate forces generated by the MENDD device.  To test radial stretch 
of the small bowel, Coda® Balloon Catheters (K032869) will be introduced 
into the volunteers’ intestine over a guide wire. The guide wire (TERUMO 
Radifocus Glidewire Angled Stiff Shaft .035" x 180cm (X) GS3508, 
K152740) is used routinely in the gastrointestinal tract as well as 
endovascularly and will be advanced under endoscopy and fluoroscopy. 
Coda® Balloons are intended for temporary occlusion of large blood 
vessels, or to expand vascular prostheses. Because of the primary 
indications, the balloon diameter must be extremely precise and accurate. 
A Coda® balloon with a similar diameter and length, compared to our 
MENDD design, will be used in the first portion of the study. Pain 
questionnaires will be administered to the subjects in real time. Due to the 
subjectivity of pain, the pain scales must be completed at the time and 
cannot be completed after the procedure is over.  The balloon will be 
inflated for 1-2 minutes.  If pain is severe, the balloon will be deflated 
immediately.  The balloon will be repositioned and attempted once more 

 
for the duration of 1-2 minutes.   
 
Volunteers who tolerate the radial stretch will move on to the second 
portion of the study. The Coda will be removed, and a Double Balloon 
Endoscope (DBE) (©FUJIFILM Healthcare, K183032) will be introduced 
retrograde into the stoma. An advanced endoscopist with specific training 
and credentialling will perform the endoscopic procedure. Typically, this 
procedure is done antegrade through the oropharynx in an anesthetized 
individual. In short, the DBE is an endoscope that has a balloon on the 
scope itself and on an overtube. The scope is advanced through the small 
bowel by alternately inflating and deflating balloons and bringing the small 
bowel to the endoscopist by pleating the bowel over the overtube, similar 
to pulling a curtain over a rod. Our procedure will deviate from the 
described use. In this study, the DBE will be introduced retrograde through 
the ileostomy and the inter-balloon distance will be increased causing 
stretch on the intestine instead of decreased causing the intestinal pleats. 
As this is a common unintentional consequence of the DBE procedure, 
safety precautions and alarms have been implemented to prevent damage 
to the intestine. The device will be left with balloons inflated on tension for 
30-60 seconds or until the device turns off due to safety measures built 
into the device.        
Visual Analog Scale Pain Scoring will be used to assess the participants 
sensation during both parts of the study.  Because pain tolerance differs 
for all people, we will not set pre-determined score in which the 
procedure will be stopped, but rather rely on the participant and their 
willingness to continue. The trial will be discontinued if three participants 
do not tolerate the first stage of this study i.e., the Coda balloons.  Pain 
during the second portion of the protocol (DBE) will not result the 
termination of the study. The dissimilar characteristics of the DBE 
balloons with the MENDD prototype balloons are the reason the Coda 
balloons are used in the first portion of the study and discomfort from the 
DBE will be noted, but in itself will not be considered a failure of the 
study.  
The VAS will be used at several timepoints beginning with immediately 
after insertion of the catheter and prior to balloon expansion. Next the 
score will be assessed after the balloon is inflated to a known diameter.  
Should the subject move to the second phase of the study, the VAS will 
be given after insertion of the DBE prior to deployment of balloons, after 
deployment of each balloon and during the extension procedure.      
 
7.0 
Study Intervention Discontinuation 
7.1 
Discontinuation of Study Intervention 
Participants may withdraw voluntarily from the study, or the PI may 
discontinue a participant from the study. Discontinuation from study 
intervention will disqualify participant from further continuation. If a 
clinically significant finding is identified (including, but not limited to 
changes from baseline) after enrollment, the investigator or qualified 
designee will determine if any change in participant management is 
needed. Any new clinically relevant finding will be reported as an 
adverse event (AE).  Participants will have access to reach the study 
team should any concerns arise, and a phone call interview will be 

 
scheduled for post procedure day 30 to assess for AEs.  
7.2 
Participant Discontinuation/Withdrawal 
Participants may withdraw voluntarily from the study or discontinue the 
study intervention at any time.   
7.3 
Loss to Follow up 
A participant will be considered lost to follow-up if he or she fails to return 
for scheduled visits or is unable to be contacted by the study site staff. 
 
8.0 
Adverse Events 
8.1 
Adverse Events and other reportable events 
Any adverse event reported or observed by the participant will be 
reported per standard IRB reporting. Adverse event means any untoward 
medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention related. Adverse events 
will be recorded from the time the consent is obtained until the final 
procedure is complete including completion of VAS and the 30 day follow 
up phone call. Other reportable information will be reported to the IRB 
according to standard reporting procedures.  
 
Expected possible adverse events include: 
 
• 
Damage to the intestinal wall ranging from mild mucosal irritation 
to full thickness injury or perforation.   
• 
Damage to the stoma 
• 
Bleeding from the intestinal lumen is usually self-limited and will 
resolve with observation. However, severe damage may require 
endoscopic or surgical evaluation and/or intervention to obtain 
hemostasis or repair perforation. 
• 
Discomfort or pain 
• 
Radiation-related risks associated with fluoroscopy include: 
radiation-induced injuries to the skin and underlying tissues 
(“burns”), which occur shortly after the exposure, and. radiation-
induced cancers 
   
9.0 
Statistical Considerations: 
9.1 
Proposed sample size (number of records to be reviewed):  
5 subjects will be enrolled.  If 3 fail to complete the radial stretch test with 
Coda balloon, the study will be terminated.  
9.2 
Proposed time period to be evaluated 
We aim to achieve our enrollment goal within 6 months of approval 
9.3 
Specify how data will be analyzed and by whom:   
Data will be reviewed and analyzed by the study team and departmental 
statistician 
 
10.0 
Supporting Documentation and Operational Considerations: 
10.1 
Informed Consent Process 
Once the study team has been notified of a potential participant, the 
study team will contact the patient via phone using a phone script (see 
appendix) or approach the participant in the pre-procedure area at which 
time the consent will be reviewed, allowing time for any follow up 

 
questions and consideration. Once the participant has agreed to 
participate, and eligibility has been confirmed and documented including 
medical history by a study member, the consent process will be 
completed.  
 
10.2 
Study Discontinuation and Closure 
At which time the study is complete and all data collection, analysis, and 
publication, if applicable is complete, the study will be terminated.  
 
10.3 
Future Use of Data 
We plan to keep this data for future use as this data will contribute to a 
future project. The data obtained will help to inform future projects and 
may be included as we further investigate this cohort/disease. Future use 
of data will be permitted and will be included in the consent.  
 
10.4 
Data Handing and Record Keeping 
All electronic data will be kept on password protected, encrypted devices 
within the University of Michigan system which meet current security 
standards. Any paper records utilized during this review will be kept in a 
locked cabinet within the Pediatric Surgery research space and/or PI’s 
office. Only study personnel approved by the IRB will have access to 
study data and records.  
 
Once data collection and analysis is complete, any PHI will be removed 
from the dataset and data will be maintained for 3 years after the study 
completion.  
 
11.0 
References: 
12.0 
Appendix 
A. Data Collection Forms with data elements to be collected 
from the medical record 
B. Patient reported pain scales 
a. See Figure 3 
C. Specification and safety information for Double Balloon 
enteroscope 
a. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c
fcfr/cfrsearch.cfm?fr=876.1500 
b. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c
fcfr/CFRSearch.cfm?CFRPart=876 
c. https://healthcaresolutions-
us.fujifilm.com/endoscopy/fujifilm-580-series-
interventional-endoscopes/fujifilm-en-580t-double-
balloon-endoscope 
 

 
  
Figure 1. Artist rendition of MENDD showing all features of the device.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Coda Balloon Fill volume curves 

 
 
Figure 3. Visual analog scale for pain assessment 
 
Figure 4. Double balloon enteroscope (©FUJIFILM) 
 

 
 
Figure 5. Adaptive study design 
 
 
Works Cited 
1. 
Spencer, A. U. et al. Pediatric short bowel syndrome: redefining predictors of success. Ann. Surg. 
242, 403 (2005). 
2. 
Spencer, A. U. et al. Pediatric short-bowel syndrome: the cost of comprehensive care. Am. J. 
Clin. Nutr. 88, 1552–1559 (2008). 
3. 
Billiauws, L., Bataille, J., Boehm, V., Corcos, O. & Joly, F. Teduglutide for treatment of adult 
patients with short bowel syndrome. Expert Opin. Biol. Ther. 17, 623–632 (2017). 
4. 
Jeppesen, P. B. Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients 
with short bowel syndrome. Ther. Adv. Gastroenterol. 5, 159–171 (2012). 
5. 
Shawe-Taylor, M. et al. Glucagon-like petide-2 acts on colon cancer myofibroblasts to stimulate 
proliferation, migration and invasion of both myofibroblasts and cancer cells via the IGF pathway. 
Peptides 91, 49–57 (2017). 
6. 
Kim, H. B. et al. Serial transverse enteroplasty (STEP): a novel bowel lengthening procedure. J. 
Pediatr. Surg. 38, 425–429 (2003). 
7. 
Bueno, J. et al. Analysis of patients with longitudinal intestinal lengthening procedure referred 
for intestinal transplantation. J. Pediatr. Surg. 36, 178–183 (2001). 
8. 
Mercer, D. F. et al. Serial transverse enteroplasty allows children with short bowel to wean from 
parenteral nutrition. J. Pediatr. 164, 93–98 (2014). 
9. 
Abu-Elmagd, K. M. et al. Evolution of clinical intestinal transplantation: improved outcome and 
cost effectiveness. in Transplantation proceedings 31, 582 (NIH Public Access, 1999). 
10. 
Lao, O. B. et al. Outcomes in children after intestinal transplant. Pediatrics peds–2009 (2010). 
11. 
Sueyoshi, R., Ignatoski, K. M. W., Okawada, M. & Teitelbaum, D. H. Distraction-induced 
intestinal growth: the role of mechanotransduction mechanisms in a mouse model of short bowel 
syndrome. Tissue Eng. Part A 20, 830–841 (2013). 
12. 
Chen, Y., Zhang, J., Qu, R., Wang, J. & Xie, Y. An animal experiment on short gut lengthening. 
Chin. Med. J. (Engl.) 110, 354–357 (1997). 
13. 
Demehri, F. R., Wong, P. M., Freeman, J. J., Fukatsu, Y. & Teitelbaum, D. H. A novel double-
balloon catheter device for fully endoluminal intestinal lengthening. Pediatr. Surg. Int. 30, 1223–1229 
(2014). 

 
14. 
Demehri, F. R., Freeman, J. J., Fukatsu, Y., Luntz, J. & Teitelbaum, D. H. Development of an 
endoluminal intestinal lengthening device using a geometric intestinal attachment approach. Surgery 158, 
802–811 (2015). 
15. 
Demehri, F. R. et al. Development of an endoluminal intestinal attachment for a clinically 
applicable distraction enterogenesis device. J. Pediatr. Surg. 51, 101–106 (2016). 
16. 
Spencer, A. U. et al. Enterogenesis in a clinically feasible model of mechanical small-bowel 
lengthening. Surgery 140, 212–220 (2006). 
17. 
Oliveira, C., de Silva, N. & Wales, P. W. Five-year outcomes after serial transverse enteroplasty 
in children with short bowel syndrome. J. Pediatr. Surg. 47, 931–937 (2012). 
18. 
Jones, B. A. et al. Report of 111 consecutive patients enrolled in the International Serial 
Transverse Enteroplasty (STEP) Data Registry: a retrospective observational study. J. Am. Coll. Surg. 216, 
438–446 (2013). 
19.  Sullins VF, Wagner JP, Walthers CM, Chiang EK, Lee SL, Wu BM, Dunn JC. Function of 
mechanically lengthened jejunum after restoration into continuity. J Pediatr Surg. 2014 Jun;49(6):971-4; 
discussion 974-5. doi: 10.1016/j.jpedsurg.2014.01.033. Epub 2014 Jan 31. PMID: 24888845.