Esophageal Replacement With a Decellularized Human Esophagus Graft

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Weight loss > 10% of body weight over last 3 months

Stenosis > 5 cm in length

Multiple strictures

Esophageal mouth stenosis

Trial design

Treatments tested in this trial

  • Replacement of the esophagus with a decellularized human esophagus graft

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations