Small Bowel VisualizationSpirusNCT00861263
The Clinical Utility of Overtube Use at the Time of Endoscopy
A study testing overtube use during enteroscopy in people with Small Bowel Visualization, run by University of Florida at 1 site in United States.
Trial summary
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Small Bowel Visualization
- What is being tested?
- overtube use during enteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects ≥ 18 years.
- Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
- Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
- Subject must be able to give informed consent.
Who cannot join
- Platelets < 75,000.
- INR > 1.6.
- NSAIDS within 48 hours of procedure.
- Pregnancy.
- Esophageal stricture.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
- Conditions
- Small Bowel Visualization
- Being tested
- overtube use during enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overtube use during enteroscopyDevice
use of overtube for the regular scheduled enteroscopy
| Study group | Role | What they receive |
|---|---|---|
| spiral overtube | Other | Any subject that has been referred for spiral enteroscopy will be asked to participate in this study. The purpose is to gather data about the technical aspects of the procedure,diagnostic capability and treatment as well as long term follow up. Receives: Device: overtube use during enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Persistent or Recurrent Bleeding
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.
Measured: up to 6 yrs after after the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startJun 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small Bowel VisualizationStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 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, Division of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861263
- Sponsor's protocol ID
- Spirus Overtube
- Acronym
- Spirus
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2009
- Last updated
- 14 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Williamson JB, Judah JR, Gaidos JK, Collins DP, Wagh MS, Chauhan SS, Zoeb S, Buscaglia JM, Yan H, Hou W, Draganov PV. Prospective evaluation of the long-term outcomes after deep small-bowel spiral enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2012 Oct;76(4):771-8. doi: 10.1016/j.gie.2012.05.025. Epub 2012 Jul 7.
PubMed 22771101Judah JR, Collins D, Gaidos JK, Hou W, Forsmark CE, Draganov PV. Prospective evaluation of gastroenterologist-guided, nurse-administered standard sedation for spiral deep small bowel enteroscopy. Dig Dis Sci. 2010 Sep;55(9):2584-91. doi: 10.1007/s10620-010-1335-x. Epub 2010 Jul 15.
PubMed 20632098
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Overtube Use at the Time of Endoscopy
- ClinicalTrials.gov ID
- NCT00861263
- Acronym / sponsor ID
- Spirus / Spirus Overtube
- Conditions
- Small Bowel Visualization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spiral overtube | Other | Device: overtube use during enteroscopyAny subject that has been referred for spiral enteroscopy will be asked to participate in this study. The purpose is to gather data about the technical aspects of the procedure,diagnostic capability and treatment as well as long term follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥ 18 years.
- Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
- Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
- Subject must be able to give informed consent.
Key exclusion criteria (6 listed)
- Platelets < 75,000.
- INR > 1.6.
- NSAIDS within 48 hours of procedure.
- Pregnancy.
- Esophageal stricture.
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 |
|---|---|---|
| overtube use during enteroscopyuse of overtube for the regular scheduled enteroscopy | Device | spiral overtube |
Primary outcome
Number of Patients With Persistent or Recurrent Bleeding
Time frame: up to 6 yrs after after the endoscopy
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22771101Williamson JB, Judah JR, Gaidos JK, Collins DP, Wagh MS, Chauhan SS, Zoeb S, Buscaglia JM, Yan H, Hou W, Draganov PV. Prospective evaluation of the long-term outcomes after deep small-bowel spiral enteroscopy in patients with obscure GI bleeding. Gastrointest Endosc. 2012 Oct;76(4):771-8. doi: 10.1016/j.gie.2012.05.025. Epub 2012 Jul 7.
- Derived from this study: PubMed 20632098Judah JR, Collins D, Gaidos JK, Hou W, Forsmark CE, Draganov PV. Prospective evaluation of gastroenterologist-guided, nurse-administered standard sedation for spiral deep small bowel enteroscopy. Dig Dis Sci. 2010 Sep;55(9):2584-91. doi: 10.1007/s10620-010-1335-x. Epub 2010 Jul 15.
Related trials for Small Bowel Visualization
Enrolling by invitation
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Environmental Enteric Dysfunction
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, Division of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing overtube use during enteroscopy in people with Small Bowel Visualization, 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 4 inclusion and 6 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 14 Apr 2014. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Persistent or Recurrent Bleeding (time frame: up to 6 yrs after after the endoscopy). 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 NCT00861263, which also lists 2 linked publications.
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 14 Apr 2014.