Benign Esophageal LesionsNCT01238913
Use of Metal Stents on Benign Esophageal Lesions
An observational study of Benign Esophageal Lesions, run by University of Florida.
Trial summary
The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Esophageal Lesions
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a medical indication for endoscopic placement of esophageal metal stent and are referred for the porcedure as part of their standard medical care will be considered for the study.
Who may be able to join
- Subject is 18 years or older
- Subject has medical indication to undergo endoscopic placement of esophageal metal stent
- Subject must be able to give informed consent
Who cannot join
- Any contraindications for endoscopic placement of esophageal metal stent
- The subject is unable to give informed consent.
About this study
Official title: Prospective Evaluation of the Clinical Utility of the Endoscopic Placement of Mental Stent for Benign Esophageal Lesions
The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.
- Conditions
- Benign Esophageal Lesions
- Being tested
- Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Endoscopic placement of an esophageal metal stent as per medical indication.
| Study group | Role | What they receive |
|---|---|---|
| benign esophageal lesions | All patients who have a benign esophageal lesion where it is medically indicated that they receive a stent. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful stenting of Benign esophageal lesions
This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.
Measured: approximately 2-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: No one met the inclusion/exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Esophageal LesionsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Draganov, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238913
- Sponsor's protocol ID
- Benign esophageal lesions
- Status last verified
- Sep 2015
- First submitted
- 5 Nov 2010
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of the Endoscopic Placement of Mental Stent for Benign Esophageal Lesions
- ClinicalTrials.gov ID
- NCT01238913
- Acronym / sponsor ID
- Benign esophageal lesions
- Conditions
- Benign Esophageal Lesions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No one met the inclusion/exclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation of using metal stents as medically indicated for the treatment of benign esophageal lesions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| benign esophageal lesions | – | Procedure: EndoscopyAll patients who have a benign esophageal lesion where it is medically indicated that they receive a stent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a medical indication for endoscopic placement of esophageal metal stent and are referred for the porcedure as part of their standard medical care will be considered for the study.
Key inclusion criteria (3 listed)
- Subject is 18 years or older
- Subject has medical indication to undergo endoscopic placement of esophageal metal stent
- Subject must be able to give informed consent
Key exclusion criteria (2 listed)
- Any contraindications for endoscopic placement of esophageal metal stent
- The subject is unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoscopyEndoscopic placement of an esophageal metal stent as per medical indication. | Procedure or surgery | benign esophageal lesions |
Primary outcome
Successful stenting of Benign esophageal lesions
Time frame: approximately 2-3 hours
This is an observational study to determine the effectiveness of stenting benign esophageal lesions with a metal stent.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Draganov, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Esophageal Lesions, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful stenting of Benign esophageal lesions (time frame: approximately 2-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.