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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01970306
Recruitment Status : Recruiting
First Posted : October 28, 2013
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Adenocarcinoma Device: MatriStem PSM Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 18, 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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


Secondary Outcome Measures :
  1. stricture formation clinically and by determination of dysphagia score [ Time Frame: 90 days postoperatively ]
    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.

  2. cost metrics [ Time Frame: postoperatively (+/- 14 days) ]
    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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970306


Contacts
Contact: Vivian Strong, MD 212-639-5056
Contact: David R. Jones, MD 212-639-6428

Locations
United States, New Jersey
Memoral Sloan Kettering Cancer Center Recruiting
Basking Ridge, New Jersey, United States
Contact: Vivian Strong, MD    212-639-5056      
United States, New York
Memorial Sloan Kettering West Harrison Recruiting
Harrison, New York, United States, 10604
Contact: Vivian Strong, MD    212-639-5056      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Vivian Strong, MD    212-639-5056      
Contact: David R. Jones, MD    212-639-6428      
Principal Investigator: Vivian Strong, MD         
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Wayne Hofstetter, MD    713-792-2121      
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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01970306     History of Changes
Other Study ID Numbers: 13-178
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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