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Evaluation of Polyflex Stenting in Esophageal Cancer Patients

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ClinicalTrials.gov Identifier: NCT00727376
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
University of Louisville

July 30, 2008
August 4, 2008
August 8, 2011
March 2008
February 2011   (Final data collection date for primary outcome measure)
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation [ Time Frame: 8 - 10 weeks ]
Same as current
Complete list of historical versions of study NCT00727376 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Evaluation of Polyflex Stenting in Esophageal Cancer Patients
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Esophageal cancer patients who have elected to have a stent placed.
Esophageal Cancer
Not Provided
Observation
Esophageal cancer patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Same as current
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00727376
08-0132
No
Not Provided
Not Provided
Robert Martin, MD, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Robert Martin, MD University of Louisville
University of Louisville
January 2010