Uterine Cavity Diseases
Conditions
Interventions
A group:Ten subjects each used a disposable electronic uterine cavity imaging catheter in conjunction with standard 5Fr and 7Fr instruments.
B group:Perform intrauterine procedures using a disposable electronic uterine cavity imaging catheter paired with a disposable uterine cavity endoscope tissue cutting device (rotary cutting head).
C group:Perform intrauterine procedures using a disposable electronic uterine cavity imaging catheter paired with a disposable uterine cavity endoscope tissue cutting device (scalpel head).
Sponsors
The First Affiliated Hospital of the University of Science and Technology of China
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in the study, the following conditions must be met: 1. Age between 18 and 65 years old; 2. Indication for endometrial surgery, such as endometrial polyps (diameter <= 3 cm), submucosal myomas (diameter <= 2 cm), or adhesions in the uterine cavity; 3. Absence of contraindications for endometrial surgery; 4. The participant or their legal guardian has a thorough understanding of the benefits and risks of the trial, is still willing to participate, and has signed an informed consent form.
Exclusion criteria
Exclusion criteria: The following conditions must be met for an individual to be ineligible: 1. Suffering from menstruation or significant bleeding from an active uterus (bleeding volume greater than menstrual flow); 2. Having a clotting disorder; 3. Unable to comply with the lithotomy position for the bladder; 4. Pregnant or breastfeeding; 5. Acute genital or pelvic inflammation; 6. Co-existing cervical malignancy or untreated genital tuberculosis; 7. Co-existing severe conditions in various systems that make surgery intolerable, including but not limited to hepatic or renal insufficiency, cardiac or pulmonary dysfunction; 8. Having participated in clinical trials involving other medications or medical devices; 9. The investigator deems the participant unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Through smoothness;Operational efficacy;Surgical success rate;Closure integrity of the hysteroscopy instrument channel; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgery time;Cutting time; | — |
Countries
China
Contacts
Public ContactGao Ting
The First Affiliated Hospital of the University of Science and Technology of China
Outcome results
None listed