Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Completed · Phase 2

Conditions studied: Esophageal Adenocarcinoma

In brief

The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.

Key facts

Study ID: NCT01970306
Run by: Memorial Sloan Kettering Cancer Center
People needed: 78
Starts: 2013-10-18
Expected to finish: 2023-02-24
Last updated by the study team: 2023-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 site, as is routine care at our institution)
Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. Including but not limited to esophagectomy or total gastrectomy.
Subject is willing to provide written informed consent
Subject is willing and able to comply with the follow-up regimen

You may not qualify if…

Pregnant or lactating women
Intraoperative evidence of metastatic or locally-unresectable disease
Patients with known sensitivity or allergy to porcine materials.
Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.

Where it is running

Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering West Harrison — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Md Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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