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NCT00613834 · ClinicalTrials.gov registry record · Phase 4
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
A Phase 4 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT00613834: Completed Phase 4 study, sponsored by Oregon Health and Science University.
NCT00613834 is a Phase 4 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613834, a Phase 4 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.
Primary Outcome
Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannul
Interventions
- DRUG Lidocaine
- DRUG Sterile Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00613834 record still lists
NCT00613834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT00613834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613834 about?
NCT00613834 is a clinical study titled "Intrauterine Lidocaine Infusion for Essure Sterilization Procedures". The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.
What is the current status of trial NCT00613834?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2007-05. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00613834?
The interventions under investigation include: Lidocaine (DRUG), Sterile Saline (DRUG).
Who is sponsoring clinical trial NCT00613834?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00613834's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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