Ensayos clínicos

Inclusion Criteria:

1. Subject ≥18 years of age

2. The patient has medical conditions requiring esophageal reconstruction, such as, but
not limited to:

1. Refractory benign esophageal strictures (RBES)

2. Esophageal perforation (full thickness)

3. Chronic/persistent esophageal fistula

4. Combination of esophageal perforations/fistula with RBES

3. The patient must have failed at least 3 previous treatment modalities to correct the
medical esophageal condition (a-d).

a. If RBES: i. Steroid treatment ii. Esophageal balloon dilation (EBD) iii. Stent use
>6 months iv. Endoscopic incisional repair

b. If esophageal perforation: i. Fibrin glue ii. Endoscopic clips and/or suturing iii.
Stent > 6 months iv. Primary surgical repair

c. If Chronic/Persistent fistula(e): i. Fibrin glue ii. Endoscopic clips and/or
suturing iii. Stent > 6 months iv. Primary surgical repair

d. If Combination Perforation/fistula with RBES i. Fibrin glue ii. Endoscopic clips
and/or suturing iii. Stent use > 6 months iv. Primary surgical repair

4. The patient must be a surgical candidate for a short segment esophageal reconstruction
(<6 cm full circumferential segmental excision)

5. 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

6. Patient must be a high-risk candidate for minimally invasive esophageal
reconstruction, based upon the investigator's determination (For example, laparoscopic
gastric pull-up (GPU) is not an option due to a medical contraindication)

7. 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

Exclusion Criteria:

1. 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).

2. Known clinical contraindication that would obfuscate the use of the covered metallic
stent to be used as an adjunct to the procedure

3. Post ablation stricture for Barrett's esophagus treated less than 1 year prior to
planned procedure

4. 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:

1. diabetes mellitus (CCI = 1)

2. connective tissue disorders (CCI=1)

3. immune compromised

4. chemotherapy (within 60 day clearance)

5. inability to tolerate major thoracotomy

6. active infection at the biopsy or thoracotomy incision site

7. peripheral vascular disease (CCI=1)

8. all patients with a CCI> 2

5. Life expectancy of less than 1 year

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

Eligibility last updated 2/28/2024. Questions regarding updates should be directed to the study team contact.