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Procedure
Esophageal Implant for Esophageal Reconstruction
Phase 1
Recruiting
Research Sponsored by Biostage, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study Summary
This trial is for a device that uses a combination of a synthetic scaffold & a patient's own stem cells to help regenerate an esophageal conduit in need of full reconstruction. Safety risks monitored by an independent committee.
Who is the study for?
This trial is for adults over 18 who've tried at least three treatments without success for esophageal conditions like strictures, perforations, or fistulas. They must need and be able to undergo a short segment esophageal reconstruction within the thoracic cavity and be considered high-risk for standard procedures.Check my eligibility
What is being tested?
The study tests the CELLSPAN Esophageal Implant (CEI), which uses a patient's stem cells on a synthetic scaffold to regenerate part of the esophagus. It's a first-in-human trial with continuous safety monitoring by an independent committee across multiple U.S. centers.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include complications from surgery, reactions to implant materials or stem cells, infection risk, and possible failure of the implant necessitating additional surgical intervention.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing death within 30 days of index procedure
The number of patients who develops continuous biologic neo-conduit within the esophagus based on CT/MRI imaging and visual endoscopic evaluation.
The number of patients who does not develop anastomotic leak or fistula that requires non-endoscopic therapy.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Short Segment Esophageal ReplacementExperimental Treatment1 Intervention
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Who is running the clinical trial?
Biostage, Inc.Lead Sponsor
Harvard Apparatus Regenerative Technology, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a procedure for Barrett's esophagus less than a year ago.I have implants near the surgery area that could interfere with the healing.I am 18 years old or older.I have tried at least 3 treatments for my esophagus condition without success.I am eligible for a surgery to remove a small part of my esophagus.I cannot undergo certain procedures like fat tissue biopsy or esophagus surgery due to other health issues.I need surgery to fix my esophagus due to severe damage or blockage.I am informed and agree to a possible surgery if the initial esophageal treatment fails.My esophageal surgery area is within my chest, not too close to my stomach or throat.I am considered high-risk for a less invasive esophagus surgery.I have a condition that prevents the safe use of metallic stents.
Research Study Groups:
This trial has the following groups:- Group 1: Short Segment Esophageal Replacement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Short Segment Esophageal Replacement a risky procedure for patients?
"Due to the early stage of this trial, Short Segment Esophageal Replacement was awarded a score of 1 on our team's safety scale. This indicates that there is limited data demonstrating its efficacy and safety."
Answered by AI
What is the current enrollment of participants in this clinical experiment?
"Affirmative. Data posted on clinicaltrials.gov affirms that the research study is currently recruiting, having been initially advertised on July 13th 2023 and newly updated as recently as July 26th 2023. The trial necessitates 10 individuals to be enrolled from a single medical centre."
Answered by AI
Is there still capacity for volunteers to participate in this experiment?
"Accurate. According to clinicaltrials.gov, this research trial is actively seeking participants and was first advertised on July 13th 2023. The study needs 10 patients from one location for completion."
Answered by AI
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