Gastrointestinal DiseasesNCT00968552
Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents
An observational study of Gastrointestinal Diseases, run by University of Florida at 1 site in United States.
Trial summary
The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Self-expandable stent placement via endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age 18 or older
Who may be able to join
- Age 18 years or older.
- Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
- Subject must be able to give informed consent.
Who cannot join
- Any contraindication to performing endoscopy.
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
- The subject is unable/unwilling to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands UF endoscopy Center
Gainesville, Florida, 32610
About this study
The investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Self-expandable stent placement via endoscopy
- Keywords
- Any Gastrointestinal problem that would require an endoscopically placed stent
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-expandable stent placement via endoscopyProcedure or surgery
Self-expandable stent placement via endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing stent placement | Patients who are scheduled to undergo stent placement via endoscopy as part of their routine medical care. Receives: Procedure: Self-expandable stent placement via endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.
Measured: at the time of stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968552
- Sponsor's protocol ID
- Stents/ERCP
- Status last verified
- Oct 2016
- First submitted
- 28 Aug 2009
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagh MS, Draganov PV. Per-oral endoscopic tunneling for restoration of the esophagus: a novel endoscopic submucosal dissection technique for therapy of complete esophageal obstruction. Gastrointest Endosc. 2017 Apr;85(4):722-727. doi: 10.1016/j.gie.2016.08.035. Epub 2016 Sep 7.
PubMed 27612924
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Utility of Endoscopically Placed Self-expandable Stents
- ClinicalTrials.gov ID
- NCT00968552
- Acronym / sponsor ID
- Stents/ERCP
- Conditions
- Gastrointestinal Diseases
- Keywords
- Any Gastrointestinal problem that would require an endoscopically placed stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Aug 2009 (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 investigators' believe that it is important to medical practice to obtain information on how expandable metal stents work in a large group of patients who have metal stents placed in the gastrointestinal system. The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing stent placement | – | Procedure: Self-expandable stent placement via endoscopyPatients who are scheduled to undergo stent placement via endoscopy as part of their routine medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 or older
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Scheduled to undergo endoscopy with placement of self-expanding stent at the University of Florida, Gainesville, FL.
- Subject must be able to give informed consent.
Key exclusion criteria (3 listed)
- Any contraindication to performing endoscopy.
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
- The subject is unable/unwilling 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 |
|---|---|---|
| Self-expandable stent placement via endoscopySelf-expandable stent placement via endoscopy | Procedure or surgery | Patients undergoing stent placement |
Primary outcome
The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement.
Time frame: at the time of stent placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 27612924Wagh MS, Draganov PV. Per-oral endoscopic tunneling for restoration of the esophagus: a novel endoscopic submucosal dissection technique for therapy of complete esophageal obstruction. Gastrointest Endosc. 2017 Apr;85(4):722-727. doi: 10.1016/j.gie.2016.08.035. Epub 2016 Sep 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases, run by University of Florida at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The purpose of this research study is to collect information on the stent placement in our facility and how the patients responded to the stent placement. (time frame: at the time of stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968552, which also lists 1 linked publication.
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 27 Oct 2016.