Esophageal Replacement With a Decellularized Human Esophagus Graft (NCT06662370) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Esophageal Replacement With a Decellularized Human Esophagus Graft
24 participantsStarted 2024-11-01
Plain-language summary
The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 to 65
* Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
* For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
* Affiliated or beneficiary of a social security scheme.
* Free written consent signed by the participant and the investigator.
Exclusion Criteria:
* Weight loss \> 10% of body weight over last 3 months
* Stenosis \> 5 cm in length
* Multiple strictures
* Esophageal mouth stenosis
* Anterior surgery close to the operative zone
* Complete anterior omentectomy
* Tumour stenosis or progressive tumour pathology
* Non-stabilized psychiatric disorders
* Participation in another interventional study
* Pregnant or breast-feeding women
* Women of childbearing age without effective contraceptive measures:
All women of childbearing age must have a negative pregnancy test prior to treatment and must agree to maintain highly effective contraception using contraceptive measures from the date of consent until 12 months due to the risks associated with anesthesia during endoscopy
* Uncontrolled sepsis
* Related to the transplant procedure
* ASA score ≥ 3,
* Severe respiratory insufficiency (FEV1 \< 1 L),
* Decompensated hepatic cirrhosis or presence of esophageal varices,
* Chronic renal insufficiency (creatinine \> 1.25 N),
* M…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Morbidity/mortality
Timeframe: At 3 months after surgery
2
Nutritional autonomy
Timeframe: At 12 months after esophageal replacement