Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Conditions
Esophageal Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms
Conditions: Keywords
Esophageal Reinforcement, ACell MatriStem, 13-178
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MatriStem PSM
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient 18 years of age or older

- Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at MSKCC (biopsy may be performed at other institutions but slides must be confirmed at MSKCC, 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

Exclusion Criteria:

- 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.
Locations
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Vivian Strong, MD - 212-639-5056
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Vivian Strong, MD - 212-639-5056
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Vivian Strong, MD - 212-639-5056
Start Date
October 2013
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page