A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Who is this study for? Adult patients with esophageal adenocarcinoma
What treatments are being studied? MatriStem PSM
Status: Active, not recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge
New York
Memorial Sloan Kettering West Harrison
Harrison
Memorial Sloan Kettering Cancer Center
New York
Texas
Md Anderson Cancer Center
Houston
Time Frame
Start Date: October 18, 2013
Estimated Completion Date: October 2023
Participants
Target number of participants: 78
Treatments
Experimental: Surgical intervention
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.
Related Therapeutic Areas
Sponsors
Collaborators: Integra LifeSciences Corporation
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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