Inclusion Criteria:

• Subject ≥ 18 years of age.
• The patient has a medical condition requiring esophageal reconstruction, such as, but not limited to:
  • Refractory benign esophageal strictures (RBES);
  • Esophageal perforation (full thickness);
  • Chronic/persistent esophageal fistula;
  • Combination of esophageal perforations/fistula with RBES.
• The patient must have failed at least 3 previous treatment modalities to correct the medical esophageal condition (a-d):
  • If RBES: i. Steroid treatment ii. Esophageal balloon dilation (EBD) iii. Stent use >1 year iv. Endoscopic incisional repair;
  • If esophageal perforation: i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent > 1 year iv. Primary surgical repair;
  • If Chronic/Persistent fistula(e): i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent > 1 year iv. Primary surgical repair;
  • If Combination Perforation/fistula with RBES i. Fibrin glue ii. Endoscopic clips and/or suturing iii. Stent use > 1 year iv. Primary surgical repair.
• The patient must be a surgical candidate for a short segment esophageal reconstruction (< 6 cm full circumferential segmental excision).
• The location of the esophageal segment for surgical resection is within the thoracic cavity, defined as, at least 4 cm above gastroesophageal junction (GEJ) and at least 4 cm below the larynx.
• The patient must be a high-risk candidate for the standard of care treatment of esophageal reconstruction, based upon the investigator’s determination. (For example, laparoscopic gastric pull-up (GPU) is not an option due to a medical contraindication).
• All patients must be made aware and must be amenable to a delayed rescue repair surgical procedure in the event the CEI fails to restore a patent durable biologic esophageal conduit.
• The patient/guardian is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations.
• The patient/guardian has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:

• Subject requires or undergoes an esophageal segmental excision > 6 cm in length.
• Esophageal segment extends < 4 cm above GEJ or <4 cm below larynx.
• Pre-existing implants/structures adjacent to target surgical location for implant that could cause abrasion of the scaffold/regenerated tissue (e.g., pacemaker lead, vascular clips, vascular grafts).
• Known clinical contraindication that would obfuscate the use of the covered metallic stent to be used as an adjunct to the procedure.
• Post-ablation stricture for Barrett’s esophagus treated less than 1 year prior to planned procedure.
• Patient has a comorbidity or contraindication that would preclude any study required procedures including adipose tissue biopsy and esophageal resection surgery. Comorbidities are defined from a subset of the Charlson Comorbidities Index (CCI, Yamashita 2018) scoring system and include:
  • Diabetes mellitus (CCI = 1);
  • Connective tissue disorders (CCI=1);
  • Immune compromised;
  • Chemotherapy (within 60 day clearance);
  • Inability to tolerate major thoracotomy;
  • Active infection at the biopsy or thoracotomy incision site;
  • Peripheral vascular disease (CCI=1);
  • All patients with a CCI ≥ 2.
• Life expectancy of less than 1 year.
• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Has a known untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial.
• Has a diagnosis of immunodeficiency, receiving cancer therapy including chimeric antigen receptor T cells (CAR-T), receiving systemic steroid therapy (>10 mg prednisone or equivalent daily dose) or any other form of pharmacologic therapy that would inhibit the intended cell growth (e.g., protease inhibitors, immunosuppressants, anti-cytokine therapies) within 30 days prior to index procedure or intended for use during any time after implantation through 12 months post-index procedure.
• Patient with an infection requiring antibiotic therapy.
• Known allergy to Nitinol (for adjunctive self-expanding covered metallic stent procedure).
• Current participation in another investigational drug or device study.
• Patient is a prisoner.
• If in the opinion of the investigator, the patient requires pain management (potentially opioid medications) as a result of study participation, the patient is at an unreasonable risk of addiction. This decision may be based upon medical or social history, personal situation, or the expected time course, length, and type of medication use.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/14/23. Questions regarding updates should be directed to the study team contact.