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Evaluation of Polyflex Stenting in Esophageal Cancer Patients

This study has been completed.
Information provided by:
University of Louisville Identifier:
First received: July 30, 2008
Last updated: August 4, 2011
Last verified: January 2010
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.

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)
Esophageal cancer patients


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.

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
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 identifier: NCT00727376

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert Martin, MD, University of Louisville Identifier: NCT00727376     History of Changes
Other Study ID Numbers: 08-0132
Study First Received: July 30, 2008
Last Updated: August 4, 2011

Keywords provided by University of Louisville:

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on August 16, 2017