Clinical trial · Observational
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
NCT03915717CI-TRIAL-00083019terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Enrollment
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Flap Transfer | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EchoMark | Device | — | UNRESOLVED |
| EchoSure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
- timeFrame
- Through study completion
- description
- Surgeon evaluation of improved monitoring ability via questionnaire with likert scale
- measure
- Surgeon Evaluation of Satisfaction
- timeFrame
- Through study completion, an average of 1 year
- description
- Surgeon evaluation of satisfaction via questionnaire with likert scale
Secondary outcomes (6)
- measure
- Flap Failure Rate
- timeFrame
- Through patient stay, up to 5 days post-op
- description
- Percentage of flaps that fail
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan * Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation * Women of childbearing potential have a negative pregnancy test Exclusion Criteria: * Age \<18 years old * Patient unable to sign informed consent * Patient participating in another investigational device or pharmacological study * Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
References
Publications (0)
Data not yet available
No reference posted for this study.