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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
ACell Inc.
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01970306
First received: October 22, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Adenocarcinoma
Device: MatriStem PSM
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • rates of anastomotic leak. [ Time Frame: up to 10 days ] [ Designated as safety issue: Yes ]
    Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium of Gastrografin swallow)


Secondary Outcome Measures:
  • stricture formation clinically and by determination of dysphagia score [ Time Frame: 90 days postoperatively ] [ Designated as safety issue: No ]
    Patients will be evaluated in the outpatient clinic and will be assigned a dysphagia score from 0-4 by the RSA. Patients reporting symptoms consistent with stricture will be evaluated with radiographic contrast swallow study or endoscopy.

  • cost metrics [ Time Frame: postoperatively (+/- 14 days) ] [ Designated as safety issue: No ]
    Data for cost metrics will be collected postoperatively through POD90 (+/- 14 days). These include metrics such as Length of Stay, Readmission, Complications, Reoperation and Total Hospital Bill.


Estimated Enrollment: 86
Study Start Date: October 2013
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: MatriStem PSM
All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970306

Contacts
Contact: Vivian Strong, MD 212-639-5056
Contact: Nabil P. Rizk, MD 212-639-8357

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Vivian Strong, MD    212-639-5056      
Contact: Nabil P. Rizk, MD    212-639-8357      
Principal Investigator: Vivian Strong, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Vivian Strong, MD    212-639-5056      
Principal Investigator: Vivian Strong, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
ACell Inc.
Investigators
Principal Investigator: Vivian Strong, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01970306     History of Changes
Other Study ID Numbers: 13-178
Study First Received: October 22, 2013
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Esophageal Reinforcement
ACell MatriStem
13-178

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014