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NCT07395622
EpiFaith Resident Learning Curve Trial
NA trial testing EpiFaith epidural syringe in Epidural Analgesia in 34 participants. Enrolling by invitation.
1 May 2026
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 34 |
| Start date | 1 September 2023 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 June 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EpiFaith epidural syringe
- Control (glass) syringe
Conditions studied
- Epidural Analgesia — all drugs for Epidural Analgesia →
- Epidural Analgesia for Labour and Delivery — all drugs for Epidural Analgesia for Labour and Delivery →
- Learning Curve — all drugs for Learning Curve →
Sponsor
Brigham and Women's Hospital
Who can join
18 and older, any sex, with Epidural Analgesia or Epidural Analgesia for Labour and Delivery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the impact of the EpiFaith® syringe on the learning curve of anesthesia residents for the labor epidural technique. Anesthesia residents with prior experience placing \< 5 labor epidurals will be enrolled. Their performance of 20 sequential labor epidural placements with either standard technique with a beveled glass syringe or the EpiFaith® syringe will be observed. Successful epidural placement over time with sequential epidural placement attempts will be measured between groups. The primary outcome will be rate of successful epidural placement. Success will be defined as a composite of 4 criteria: maximum 3 attempts for placement; no need to re-site at a different level; no required intervention by the supervising attending anesthesiologist; and adequate analgesia with a visual analog score (VAS) \<3 at 30 minutes. We hypothesize that use of the EpiFaith® syringe will enable a faster learning curve for successful epidural placement. A cumulative sum chart (CUSUM) analysis will evaluate whether the EpiFaith® syringe causes deviation from the control learning curve. Secondary outcomes will include rate of inadvertent dural puncture and epidural replacement rate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07395622
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07395622 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 9 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07395622.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing