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Endoscopic Tissue Cutting and Abdominal Extraction Device vs. Conventional Cold Scalpel

Study acronym: SOLENDO-1
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Dec 17, 2026 to Sep 13, 2026
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Eligibility criteria expanded, about 3 words
    • Study description expanded, about 3 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 17, 2025 to Nov 13, 2025
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
91 trials monitored
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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.
Trial Details
NCT Number NCT07226375
Lead Sponsor Ege University
Conditions
(from sponsor)
Laparoscopic Hysterectomy
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov