Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656286
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Hysteroscopic Intrauterine Suturing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope
Primary outcome
Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed
Secondary outcome
Procedure complications Study Design Interventional pilot Study
Study group
Women undergoing laparoscopic hysterectomy
Primary outcome
Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed
Secondary outcome
Procedure complications Study Design Interventional pilot Study
Study group
Women undergoing laparoscopic hysterectomy
Detailed Description:
Introduction
A hysteroscopy is a procedure used to examine and treat the inside of the uterus
Apollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy
The aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope
Study Design Interventional pilot study
Study group
Women undergoing laparoscopic hysterectomy
Inclusion criteria
Benign indication for hysterectomy
Exclusion from the study
Evidence or suspicious for malignancy
Sample size calculation
Pilot study of 2 patients
Primary outcome
Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed
Secondary outcome
Procedure complications
Recruitment
The recruitment of the patients will be done at the gynecology department before the surgery
Procedure
After general anesthesia and entering the abdomen with the laparoscope Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity Insertion of normal saline to the cavity and applying 4 points suturing to the uterus The procedure will be monitored by external laparoscopic camera located in the abdominal cavity After the hysterectomy the uterus will be opened and the suture will be examine
A preoperative intrauterine incision using a hysteroscope followed by suturing will be considered based on the success of the first procedure
CRF
Demographics information obstetrics and gynecology information surgery type surgery indication
Procedure duration success amount of fluid used cervical dilatation complications
A hysteroscopy is a procedure used to examine and treat the inside of the uterus
Apollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy
The aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope
Study Design Interventional pilot study
Study group
Women undergoing laparoscopic hysterectomy
Inclusion criteria
Benign indication for hysterectomy
Exclusion from the study
Evidence or suspicious for malignancy
Sample size calculation
Pilot study of 2 patients
Primary outcome
Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed
Secondary outcome
Procedure complications
Recruitment
The recruitment of the patients will be done at the gynecology department before the surgery
Procedure
After general anesthesia and entering the abdomen with the laparoscope Truclear hysteroscope with X-tack attached will be inserted to the uterine cavity Insertion of normal saline to the cavity and applying 4 points suturing to the uterus The procedure will be monitored by external laparoscopic camera located in the abdominal cavity After the hysterectomy the uterus will be opened and the suture will be examine
A preoperative intrauterine incision using a hysteroscope followed by suturing will be considered based on the success of the first procedure
CRF
Demographics information obstetrics and gynecology information surgery type surgery indication
Procedure duration success amount of fluid used cervical dilatation complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None