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

NCT07226375 | Recruiting FDA Device

• 1 other identifier: BBAP.2023.003
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Hysterectomy

Keywords

laparoscopic hysterectomy; morcellation; tissue extraction

Outcome Measures

Primary Outcomes (1)

• Morcellation Time

  The time required for complete vaginal morcellation of the uterus, measured from the placement of the uterus into the retrieval bag until complete specimen removal. A shorter duration indicates higher procedural efficiency.

  From placement of uterus in retrieval bag to complete removal of specimen, measured in minutes (approximately 0-30 minutes).

Secondary Outcomes (1)

• Change in Female Sexual Function Index (FSFI) Score

  Baseline (within 1 week before surgery) and 6 months after operation.

Study Arms (2)

Endoscopic Tissue Cutting and Abdominal Extraction Device

EXPERIMENTAL

In the cases included in the group, vaginal morcellation will be performed with an endoscopic tissue cutting and removal device after laparoscopic hysterectomy.

Device: Vaginal tissue morcellation with extraction device

Conventional Cold Scalpel

ACTIVE COMPARATOR

In the cases included in the group, vaginal morcellation will be performed with a cold scalpel after laparoscopic hysterectomy.

Device: Vaginal tissue morcellation with scalpel

Interventions

Vaginal tissue morcellation with extraction device DEVICE

Vaginal tissue morcellation after laparoscopic hysterectomy with Endoscopic Tissue Cutting and Abdominal Extraction Device

Endoscopic Tissue Cutting and Abdominal Extraction Device

Vaginal tissue morcellation with scalpel DEVICE

Vaginal tissue morcellation after laparoscopic hysterectomy with cold scalpel

Conventional Cold Scalpel

Eligibility Criteria

• Age: 35 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned laparoscopic hysterectomy
• Estimated uterine weight of 500 g or more

You may not qualify if:

• Sexual inactivity

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Izmir Bakircay University

Izmir, 35665, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Device Removal

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Sabahattin A Arı, Associate Professor

CONTACT

+905547139994; s.anil.ari.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 10, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)