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NCT00727376 Clinical Trial

Evaluation of Polyflex Stenting in Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

Official title:
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00727376
Other study ID # 08-0132
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2008
Est. completion date February 2011

Study information
Verified date March 2018
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation 8 - 10 weeks
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