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Evaluation of Polyflex Stenting in Esophageal Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727376
First Posted: August 4, 2008
Last Update Posted: August 8, 2011
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. Read our disclaimer for details.
Information provided by:
University of Louisville
  Purpose
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.

Condition
Esophageal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation [ Time Frame: 8 - 10 weeks ]

Estimated Enrollment: 26
Study Start Date: March 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Esophageal cancer patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Esophageal cancer patients who have elected to have a stent placed.
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Willing and able to provide informed consent
  • Willing to comply with follow-up requirements
  • Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
  • Indicated for chemotherapy and/or radiation therapy
  • Ability to dilate stricture to 15mm diameter at extent of disease evaluation
  • Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent

Exclusion Criteria:

  • Patients contraindicated for endoscopy
  • Patients with prior esophageal stent placements
  • Advance stage of disease, greater than T3 tumor or M1 disease
  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): NCT00727376


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Robert Martin, MD University of Louisville
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Martin, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00727376     History of Changes
Other Study ID Numbers: 08-0132
First Submitted: July 30, 2008
First Posted: August 4, 2008
Last Update Posted: August 8, 2011
Last Verified: January 2010

Keywords provided by University of Louisville:
esophageal
stenting

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases