Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996809
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-08-11
Brief Title:
PMCF Study for COSEAL in Gynecologic Surgery
Sponsor:
Baxter Healthcare Corporation
Organization:
Baxter Healthcare Corporation
Study Overview
Official Title:
Post-Market Clinical Follow-up Study for COSEAL in Gynecologic Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None