Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01970306 | Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material | PHASE2 | COMPLETED | 78 | — | — | Oct 18, 2013 | Feb 24, 2023 | Nov 3, 2023 | 4 | United States |
Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)
| Arm | Type | Description |
|---|---|---|
| Surgical intervention | EXPERIMENTAL | Patients will undergo standard resection and gastrointestinal anastomosis and will then have reinforcement of the anastomosis with MatriStem PSM. Patients undergoing esophagectomy, PG or TG will be evaluated with one routine postoperative contrast swallow study at post-operative day #4-10. |
| Name | Type | Description |
|---|---|---|
| MatriStem PSM | DEVICE | All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM. |
Inclusion Criteria: * Patient 18 years of age or older * Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating si...