Short Bowel SyndromeNCT05535361
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
A study testing Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome in people with Short Bowel Syndrome, run by Eclipse Regenesis, Inc. at 5 sites in United States.
Trial summary
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome Read more about this study
- Who is it for?
- Ages 3 months to 65 years
- Conditions the study is for
- Short Bowel Syndrome
- What is being tested?
- Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Sep 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection.
- Minimum residual bowel length of 3 cm.
- Male or female patients aged 3 mo to 65 years inclusive
- The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent.
- The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).
Who cannot join
- Ultra-short bowel syndrome defined as less than 3 cm of bowel length.
- Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
- Evidence of active or prior Crohn's disease.
- Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
- Coagulopathy, as defined by INR > 1.4 or platelets < 100.
- Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
- Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Meghan Fitzgerald, (617) 355-4729, Meghan.Fitzgerald@childrens.harvard.edu
Mark Puder, MD
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229-3026
Beth Cobb, 405-850-1349, Beth.Cobb@cchmc.org
Michael Helmrath, MD
- Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94303
Shweta Namjoshi, MD, (650) 721-2250, namjoshi@stanford.edu
Shweta Namjoshi, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Matthew Lin, MD, (415) 476-0972, Matthew.Lin@ucsf.edu
Matthew Lin, MD
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Clarivet Torres, MD, 202-476-2115, ctorres@childrensnational.org
Clarivet Torres, MD
About this study
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome
Read the detailed description
This clinical investigation is a study to evaluate safety and probable benefit of the Eclipse XL1 System in pediatric and adult subjects with short bowel syndrome. This study is a single arm study and will enroll subjects ages 3 months to 65 years old at up to 10 study sites in the United States. This study will be open label; treatment allocation will be known by the subjects, the Principal Investigator and his medical staff. Recruitment is expected to occur over the course of 24-36 months.
Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for a portion or the entire length of study, depending on subject health.
- Conditions
- Short Bowel Syndrome
- Being tested
- Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome
- Keywords
- short bowel syndrome, intestinal failure, Necrotizing enterocolitis, short gut, intestinal volvulus, intestinal atresia
- Medical subject headings
- Short Bowel Syndrome, Intestinal Failure, Enterocolitis, Necrotizing, Intestinal Volvulus, Intestinal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction Enterogenesis in Adult Patients with Short Bowel SyndromeDevice
The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.
| Study group | Role | What they receive |
|---|---|---|
| Eclipse XL1 Coil Treatment Group | Experimental | All subjects will be assigned to the XL1 Coil treatment group. Receives: Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device and procedure related adverse events
Incident rate of moderate or severe procedure and/or device related adverse events
Measured: 4 to 6 months
Secondary outcomes (2)
Assess the lengthening of the small intestine
Assess the lengthening of the small intestine via the Eclipse XL1 Coil.
Measured: 4 to 6 months
Improvement in overall nutritional status
Improvement in overall nutritional status at 6 months post final implantation compared to pre-procedure as evidenced by change in parenteral, enteral, oral intake; stool frequency and quality; weight.
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start15 Sep 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eclipse Regenesis, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Medical Center, Cincinnati, University of California, San Francisco, Boston Children's Hospital, Lucile Packard Children's Hospital at Stanford, Children's National Health System, Washington DC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535361
- Sponsor's protocol ID
- CLIN-0001
- Other IDs
- R44DK127658
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Park J, Puapong DP, Wu BM, Atkinson JB, Dunn JC. Enterogenesis by mechanical lengthening: morphology and function of the lengthened small intestine. J Pediatr Surg. 2004 Dec;39(12):1823-7. doi: 10.1016/j.jpedsurg.2004.08.022.
PubMed 15616941Chang PC, Mendoza J, Park J, Lam MM, Wu B, Atkinson JB, Dunn JC. Sustainability of mechanically lengthened bowel in rats. J Pediatr Surg. 2006 Dec;41(12):2019-22. doi: 10.1016/j.jpedsurg.2006.08.014.
PubMed 17161196Mendoza J, Chang CY, Blalock CL, Atkinson JB, Wu BM, Dunn JC. Contractile function of the mechanically lengthened intestine. J Surg Res. 2006 Nov;136(1):8-12. doi: 10.1016/j.jss.2006.01.027. Epub 2006 Sep 18.
PubMed 16979663Shekherdimian S, Scott A, Chan A, Dunn JC. Intestinal lengthening in rats after massive small intestinal resection. Surgery. 2009 Aug;146(2):291-5. doi: 10.1016/j.surg.2009.03.034. Epub 2009 Jun 21.
PubMed 19628087
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05535361
- Acronym / sponsor ID
- CLIN-0001
- Conditions
- Short Bowel Syndrome
- Keywords
- short bowel syndrome, intestinal failure, Necrotizing enterocolitis, short gut, intestinal volvulus, intestinal atresia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eclipse Regenesis, Inc.University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Medical Center, Cincinnati, University of California, San Francisco, Boston Children's Hospital, Lucile Packard Children's Hospital at Stanford, Children's National Health System, Washington DC
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome
Detailed description
This clinical investigation is a study to evaluate safety and probable benefit of the Eclipse XL1 System in pediatric and adult subjects with short bowel syndrome. This study is a single arm study and will enroll subjects ages 3 months to 65 years old at up to 10 study sites in the United States. This study will be open label; treatment allocation will be known by the subjects, the Principal Investigator and his medical staff. Recruitment is expected to occur over the course of 24-36 months.
Device placement will be administered during a standalone procedure or a previously planned procedure that is otherwise needed by the study subject. Subjects may receive up to 2 devices at one time and/or have multiple procedures over time based on clinical necessity Study objectives will be monitored by reviewing patient nutrition, weight, and stool assessment data. The study device will also monitored by radiographic examination to confirm location of the device and assess the safety and probable benefit of distraction enterogenesis until the device is removed or passes out of the intestine naturally. Patients will be followed while the study device is in situ and at 3 and 6 months post device passing or removal. Subjects may or may not be discharged from the hospital while participating in the study, and investigators may recommend that a subject stay in-patient for a portion or the entire length of study, depending on subject health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eclipse XL1 Coil Treatment Group | Experimental | Device: Distraction Enterogenesis in Adult Patients with Short Bowel SyndromeAll subjects will be assigned to the XL1 Coil treatment group. |
Who may qualify
- Ages
- 3 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and/or height, and measured at the time of the subject's prior intestinal resection.
- Minimum residual bowel length of 3 cm.
- Male or female patients aged 3 mo to 65 years inclusive
- The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent.
- The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).
Key exclusion criteria (7 listed)
- Ultra-short bowel syndrome defined as less than 3 cm of bowel length.
- Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)
- Evidence of active or prior Crohn's disease.
- Primary intestinal failure (i.e., without loss or resection of intestinal tissue).
- Coagulopathy, as defined by INR > 1.4 or platelets < 100.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction Enterogenesis in Adult Patients with Short Bowel SyndromeThe surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy. | Device | Eclipse XL1 Coil Treatment Group |
Primary outcome
Device and procedure related adverse events
Time frame: 4 to 6 months
Incident rate of moderate or severe procedure and/or device related adverse events
2 secondary outcomes
Assess the lengthening of the small intestine
Time frame: 4 to 6 months
Improvement in overall nutritional status
Time frame: 6 to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 15616941Park J, Puapong DP, Wu BM, Atkinson JB, Dunn JC. Enterogenesis by mechanical lengthening: morphology and function of the lengthened small intestine. J Pediatr Surg. 2004 Dec;39(12):1823-7. doi: 10.1016/j.jpedsurg.2004.08.022.
- Background: PubMed 17161196Chang PC, Mendoza J, Park J, Lam MM, Wu B, Atkinson JB, Dunn JC. Sustainability of mechanically lengthened bowel in rats. J Pediatr Surg. 2006 Dec;41(12):2019-22. doi: 10.1016/j.jpedsurg.2006.08.014.
- Background: PubMed 16979663Mendoza J, Chang CY, Blalock CL, Atkinson JB, Wu BM, Dunn JC. Contractile function of the mechanically lengthened intestine. J Surg Res. 2006 Nov;136(1):8-12. doi: 10.1016/j.jss.2006.01.027. Epub 2006 Sep 18.
- Background: PubMed 19628087Shekherdimian S, Scott A, Chan A, Dunn JC. Intestinal lengthening in rats after massive small intestinal resection. Surgery. 2009 Aug;146(2):291-5. doi: 10.1016/j.surg.2009.03.034. Epub 2009 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome in people with Short Bowel Syndrome, run by Eclipse Regenesis, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Bessette ((617)249-0955, andre@eclipseregenesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device and procedure related adverse events (time frame: 4 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535361, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.