NCT07226375 Endoscopic Tissue Cutting and Abdominal Extraction Device vs. Conventional Cold Scalpel
| NCT ID | NCT07226375 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ege University |
| Condition | Laparoscopic Hysterectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2026-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-11-13 with a primary completion date of 2026-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to compare the surgical tissue removal success of the endoscopic tissue cutting device, which was designed by the conductor and developed with the support of TUBITAK-1512 project and for which Turkish and European patent applications were made, with the conventional cold scalpel. Laparoscopic surgeries are performed through incisions ranging from 0.5 cm to 1 cm. After the operation, much larger masses need to be removed from the abdomen compared to these incisions. Currently, in laparoscopic surgery, masses are removed from the abdomen by cutting them into pieces with a scalpel, using electrical devices called power morcellators that are used to cut the tissue/mass with rotational movement and remove it from the abdomen, and directly removing the mass from the abdomen through an incision made as large as the size of the mass. Trying to remove large tissues/mass by dissecting them with a scalpel through incisions that are 1.5-2 cm wide and limit the surgeon's range of motion is quite laborious, tiring, time-consuming and risky. In the use of Power Morcellator disintegrator devices, there is a risk of the pieces of the mass spreading into the abdomen while cutting and separating the tissue/mass that is being removed into small pieces due to the rotational movement in the working principle. In operations where the Power Morcellator device is used, if the removed tissue is malignant (cancerous), the patient faces the risk of metastasis spreading to the entire abdomen. Due to these risks, the use of power morcellator devices has been completely banned in the United States, and in European Union countries, it has been required that the device be operated in protective bags. The invention is a medical device that will allow large masses to be removed quickly, safely and easily through small incisions in closed surgeries. The device offers an effective solution to the problems of the current technique. Within the scope of the study, the morcellator scissors and the scalpel, which are designed and started to be mass-produced, will be compared in the morcellation (removal by separating into pieces) process to be performed during the removal of the mass from the vagina after laparoscopic hysterectomy surgeries, and the morcellation time, possible complications and the possible effects of the device to be used on the case will be investigated.
Eligibility Criteria
Inclusion Criteria: * Planned laparoscopic hysterectomy * Estimated uterine weight of 500 g or more Exclusion Criteria: * Sexual inactivity
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07226375 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 65 Years, studying Laparoscopic Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07226375 currently recruiting?
Yes, NCT07226375 is actively recruiting participants. Contact the research team at s.anil.ari.md@gmail.com for enrollment information.
Where is the NCT07226375 trial being conducted?
This trial is being conducted at Izmir, Turkey (Türkiye).
Who is sponsoring the NCT07226375 clinical trial?
NCT07226375 is sponsored by Ege University. The trial plans to enroll 84 participants.