Distraction Enterogenesis Device for Short Bowel Syndrome

Recruiting at 5 trial locations

Overseen By Eric Bannon

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Eclipse Regenesis, Inc.

Disqualifiers: Crohn's, Coagulopathy, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 37

Duration: 4 to 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Eclipse XL1 System, designed to assist individuals with short bowel syndrome. The goal is to determine if this device can safely promote bowel growth, potentially improving nutrient absorption. Individuals who have had a significant portion of their bowel removed but have at least 3 cm remaining may be suitable candidates. Participants must be prepared to attend all clinic visits and adhere to study procedures. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatments for short bowel syndrome.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for guidance.

What prior data suggests that the Eclipse XL1 System is safe for patients with Short Bowel Syndrome?

Research has shown that the Eclipse XL1 System is under testing to determine its safety and effectiveness for children and adults with short bowel syndrome. Currently, specific information about side effects or patient tolerance is unavailable, indicating that the treatment remains in early testing stages. Researchers are primarily focused on assessing the device's safety and utility for patients. As this is an initial study, more detailed safety information will likely emerge from future research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Short Bowel Syndrome focus on dietary management, medication to slow down digestion, or surgical options to lengthen the bowel. However, the Eclipse XL1 System introduces a novel approach by using a device called the Distraction Enterogenesis Device. This system aims to encourage the growth of new intestinal tissue, potentially increasing the absorptive area of the bowel without the need for complex surgeries. Researchers are excited about this treatment because it offers a less invasive option that could significantly improve nutrient absorption and overall quality of life for patients with this challenging condition.

What evidence suggests that the Eclipse XL1 System is effective for Short Bowel Syndrome?

Research has shown that the Eclipse XL1 System, which participants in this trial will receive, can help grow new small intestine tissue in people with short bowel syndrome. This is important because it can improve nutrient absorption, a common issue for these patients. In early human trials, the device safely encouraged tissue growth. Initial findings suggest that the Eclipse XL1 System might offer a new way to manage short bowel syndrome, potentially enhancing the quality of life for those affected. While more research is needed, these early results are promising. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-50 with Short Bowel Syndrome (SBS), having at least 10 cm of remaining bowel, who are scheduled for an unrelated open abdominal surgery. They must understand the study and commit to follow-up visits. Excluded are those with ultra-short SBS, recent bowel surgeries, inflammatory diseases other than Crohn's or ulcerative colitis, coagulopathy, compromised immune systems, or deemed unsuitable by the investigator.

Inclusion Criteria

I have at least 10 cm of my bowel remaining.

I am scheduled for an open abdominal surgery not related to the study device.

The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent

Exclusion Criteria

I had surgery on my intestines less than 6 months ago.

My intestines are failing without any part being removed.

I have or had Crohn's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Device placement and monitoring for intestinal lengthening and safety assessments

4 to 6 months

Daily visits for 7 days post-operatively, then weekly until device passage or removal

Follow-up

Participants are monitored for safety and effectiveness after device removal or passage

4 weeks

Follow-up 30 days after device removal or passage

What Are the Treatments Tested in This Trial?

Interventions

• Eclipse XL1 System

Trial Overview The Eclipse XL1 System is being tested in adults with SBS to see if it's safe and beneficial. Up to five participants will be enrolled across two U.S. sites to undergo Distraction Enterogenesis—a process aimed at lengthening the small intestine—during a scheduled abdominal surgery.

How Is the Trial Designed?

Group I: Eclipse XL1 Coil Treatment Group Experimental Treatment 1 Intervention

All subjects will be assigned to the XL1 Coil treatment group.

Who Is Running the Clinical Trial?

Eclipse Regenesis, Inc.

Lead Sponsor

Trials

1

Recruited

20+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Lucile Packard Children's Hospital at Stanford

Collaborator

Children's National Health System, Washington DC

Collaborator

Published Research Related to This Trial

In a study involving juvenile mini-Yucatan pigs, the use of multiple compressed nitinol springs secured with intestinal plication resulted in a significant increase in intestinal length, from 2.5 cm to 3.9 cm per spring, demonstrating a promising method for treating short bowel syndrome.

The procedure was safe, as all pigs tolerated their diets post-surgery, showed continued weight gain, and experienced no intestinal dilation or obstruction, indicating that this method does not compromise intestinal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intestinal lengthening via multiple in-continuity springs. Dubrovsky, G., Huynh, N., Thomas, AL., et al.[2019]

Human and pig small intestines can safely withstand distractive forces up to 235-295 gram-force before experiencing gross tissue disruption, with the presence of mesentery increasing stiffness in pig bowel but not affecting human bowel.

Blood flow to the bowel wall is significantly compromised at loads exceeding 100 gram-force, indicating that while the tissue can tolerate higher forces, excessive loads may risk ischemia, which is crucial for guiding the clinical application of distraction enterogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of distractive forces to the small intestine: defining safe limits. Miyasaka, EA., Okawada, M., Utter, B., et al.[2021]

In a study involving juvenile mini-Yucatan pigs, the use of self-expanding endoluminal springs for in-continuity intestinal lengthening showed promising results, achieving a 1.47-fold increase in jejunal length without causing bowel obstruction for up to 29 days.

Histological analysis revealed that the lengthened jejunum exhibited increased crypt depth and muscularis thickness, indicating potential improvements in intestinal health and function, marking the first demonstration of safety and efficacy for this method in a porcine model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spring-mediated distraction enterogenesis in-continuity. Huynh, N., Rouch, JD., Scott, A., et al.[2018]

A new double-balloon catheter device was successfully tested in Yorkshire pigs, showing that it can safely increase the length of the small intestine by 26.1% over 7 days without significantly affecting blood flow to the bowel.

This endoluminal device may offer a promising new treatment for short bowel syndrome (SBS) by promoting intestinal growth, with observed increases in bowel length of up to 12.9 cm in unfed conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel double-balloon catheter device for fully endoluminal intestinal lengthening. Demehri, FR., Wong, PM., Freeman, JJ., et al.[2021]

A new catheter device was successfully used in Yorkshire pigs to increase the length of the small intestine by 37% after 7 days and 80% after 14 days, demonstrating its potential for treating short bowel syndrome.

The method showed no complications such as perforation or stoma-related issues, indicating a safe approach for endoluminal distraction enterogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an endoluminal intestinal lengthening device using a geometric intestinal attachment approach. Demehri, FR., Freeman, JJ., Fukatsu, Y., et al.[2019]

The novel telescopic hydraulic device with a dilating fenestrated elastic mask (DFM) allowed for effective endoluminal distraction enterogenesis in Yorkshire pigs without causing tissue injury or reducing bowel perfusion, demonstrating a safe method for bowel lengthening.

After 7 days of using the device, the distracted bowel showed a significant 44% increase in length compared to non-distracted bowel, indicating that this method could be a viable alternative to traditional surgical techniques for treating short bowel syndrome (SBS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an endoluminal intestinal attachment for a clinically applicable distraction enterogenesis device. Demehri, FR., Utter, B., Freeman, JJ., et al.[2018]

In a study involving rats, a degradable spring device successfully lengthened the jejunum, and after restoration, the segments showed normal peristalsis and significant absorption of glucose and water, indicating effective absorptive function.

The restored jejunal segments exhibited structural improvements, such as thicker smooth muscle and increased villus height, suggesting that distraction enterogenesis could be a promising treatment for patients with short bowel syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Function of mechanically lengthened jejunum after restoration into continuity. Sullins, VF., Wagner, JP., Walthers, CM., et al.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05535361?cond=%22Intestinal%20Volvulus%22&aggFilters=status:not%20rec&rank=1

NCT05535361 | A Feasibility Study to Evaluate Safety and ... 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 ...

2. reporter.nih.gov reporter.nih.gov/search/10E0CF0D4784C5DE7598B8961CAA4A01A2FFCEB861BF/project-details/11253598

RePORT RePORTER - National Institutes of Health (NIH) | Outcomes study for the XL1 distraction enterogenesis device to improve nutrient absorption in short bowel syndrome patients. Project Number2R44DK127658-04.

3. fogartyinnovation.org fogartyinnovation.org/eclipse-regenesis-reaches-first-in-human-milestone-with-treatment-for-short-bowel-syndrome/

Eclipse Regenesis Reaches First-in-Human Milestone with ... “But while the device was in place, it appeared to safely stimulate the growth of new small intestine tissue.” Two months after treatment, it ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05535361

Feasibility Study to Evaluate Safety and Probable Benefit of ... 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 ...

5. eclipseregenesis.com eclipseregenesis.com/2024/04/25/the-eclipse-xl1-revolutionizing-the-treatment-of-short-bowel-syndrome/

Revolutionizing the Treatment of Short Bowel Syndrome The Eclipse XL1 is not just a new treatment option; it represents a paradigm shift in the management of Short Bowel Syndrome. Its development is ...

6. reporter.nih.gov reporter.nih.gov/project-details/10705620

Intestinal Lengthening via Distraction Enterogenesis for the ... The Phase I portion of the project will produce the pre-clinical safety data on the final design of the Eclipse XL1 distraction enterogenesis device required ...

7. med.stanford.edu med.stanford.edu/content/sm/sleepdivision/research/clinicaltrials/results.html?ctid=NCT05535361&conditionId=&serviceLineId=&condition=&alpha=a

Clinical Trials results | Division of Sleep Medicine A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short ...