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Distraction Enterogenesis

Distraction Enterogenesis Device for Short Bowel Syndrome

N/A

Recruiting

Research Sponsored by Eclipse Regenesis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 to 6 months

Awards & highlights

Study Summary

This trial tests a device to help adults with short bowel syndrome. It's enrolling up to 5 people at 2 sites in the US.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed for this early-stage trial, potential risks may include complications from surgery such as infection or bleeding, adverse reactions to device materials or procedures involved in Distraction Enterogenesis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Device and procedure related adverse events

Secondary outcome measures

Assess the lengthening of the small intestine

Trial Design

1Treatment groups

Experimental Treatment

Group I: Eclipse XL1 Coil Treatment GroupExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eclipse Regenesis, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for involvement in this medical experiment?

"Candidates must possess short bowel syndrome and be between 18 to 50 years old in order to participate. Ultimately, the study is looking for a total of 18 patients."

Answered by AI

Are there any slots left in this medical trial for volunteers?

"According to clinicaltrials.gov, this medical study is still recruiting patients and was first published on January 15th 2023 with its most recent update taking place in October 13th 2023."

Answered by AI

Are septuagenarians eligible to apply for this medical research?

"This clinical trial is seeking participants aged 18-50. There are 374 trials for those under the age of majority and 1044 studies that target individuals over 65 years old."

Answered by AI

What is the overall participation rate in this medical trial?

"Affirmative. The trial's particulars, which were initially released on January 15th 2023 and recently amended on October 13th of the same year, are documented clinicaltrials.gov; 18 volunteers will be recruited from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS

2023. "A Feasibility Study to Evaluate Safety & Benefit of Eclipse XL1 System in Adult Patients With SBS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05535361.