Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05996809 · ClinicalTrials.gov registry record
PMCF Study for COSEAL® in Gynecologic Surgery
A clinical trial of Adhesion, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- 200
- Enrollment target
- 2
- Study locations
NCT05996809: Completed study of Adhesion, sponsored by Baxter Healthcare Corporation.
NCT05996809 is a study of Adhesion that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 200 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05996809, a study of Adhesion, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Patient charts will be reviewed to collect the data on readmissions related to adhesions, which are defined as: * Directly related to adhesions (adhesiolysis, non-operative readmissions for adhesions, and adhesiolysis operations on female reproductive tract); * Possibly related to adhesions (gynecologic operations, abdominal surgery, and nonoperative readmissions); * Open or laparoscopic reoperations that could potentially be complicated by present adhesions
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 |
What the finished NCT05996809 record still lists
NCT05996809 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT05996809 reports a single indexed study location in Illinois, Rome.
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.
What interventions are being tested in trial NCT05996809?
The interventions under investigation include: Coseal (DEVICE).
Who is sponsoring clinical trial NCT05996809?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI