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PMCF Study for COSEAL® in Gynecologic Surgery
NCT05996809 · View on ClinicalTrials.gov ↗
Study Summary
The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients. Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.
Conditions Studied
Interventions
- DEVICE Coseal
Study Locations (2)
Illinois
- Feinberg School of Medicine — Chicago
Rome
- Universita Campus Bio Medico di Roma — Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2025-05-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05996809
The ClinicalTrials.gov registry entry for NCT05996809 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxter Healthcare Corporation, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Adhesion appearing as the primary indexed condition, and to 1 intervention — of which Coseal is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05996809 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Rome. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05996809 about?
NCT05996809 is a clinical study titled "PMCF Study for COSEAL® in Gynecologic Surgery". The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which C...
What is the current status of trial NCT05996809?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2024-06-03. Estimated completion is 2025-05-08.
What conditions does trial NCT05996809 study?
This clinical trial studies the following conditions: Adhesion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05996809?
The interventions under investigation include: Coseal (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05996809?
This trial is sponsored by Baxter Healthcare Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05996809 being conducted?
This trial has 2 study locations across Illinois, Rome. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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