Evaluation of Polyflex Stenting in Esophageal Cancer Pati... | NCT00727376

Studies
Evaluation of Polyflex Stenting in Esophageal Cancer Patients

NCT00727376

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Aug 3, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Esophageal Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jul 30, 2008

First Submission Date that Met QC Criteria

Aug 1, 2008

First Posted Date

Aug 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Aug 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
Observation		Esophageal cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation		8 - 10 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Esophageal cancer patients who have elected to have a stent placed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Martin, MD	University of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Louisville		Louisville	Kentucky	40202	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24567281	Derived	Martin RC 2nd, Cannon RM, Brown RE, Ellis SF, Williams S, Scoggins CR, Abbas AE. Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer. Oncologist. 2014 Mar;19(3):259-65. doi: 10.1634/theoncologist.2013-0344. Epub 2014 Feb 24.
21463793

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms