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NCT01133288 · ClinicalTrials.gov registry record · NA
Yulex Glove Prospective Study in Spina Bifida
A NA study, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- Terminated
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT01133288 is a NA study that was terminated before completion, run by Hugo W. Moser Research Institute at Kennedy Krieger. The registered enrollment target is 7 participants.
The verdict
NCT01133288, a NA study, was terminated before completion, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger.
- TERMINATED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein. Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy. In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period. The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data. Individuals with a history of anaphylaxis will be excluded from the study. The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study. The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.
Interventions
- DEVICE Yulex gloves
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01133288
The ClinicalTrials.gov registry entry for NCT01133288 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Yulex gloves is the first listed.
NCT01133288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01133288 about?
NCT01133288 is a clinical study titled "Yulex Glove Prospective Study in Spina Bifida". This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in...
What is the current status of trial NCT01133288?
This trial is currently terminated. It is a NA study. The enrollment target is 7 participants. The study started on 2009-07. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01133288?
The interventions under investigation include: Yulex gloves (DEVICE).
Who is sponsoring clinical trial NCT01133288?
This trial is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, which has 73 total clinical trials registered on ClinicalTrials.gov.
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