Laparoscopic HysterectomySOLENDO-1NCT07226375
Endoscopic Tissue Cutting and Abdominal Extraction Device vs. Conventional Cold Scalpel
A study testing Vaginal tissue morcellation with extraction device and Vaginal tissue morcellation with scalpel in people with Laparoscopic Hysterectomy, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Vaginal tissue morcellation with extraction device and Vaginal tissue morcellation with scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2025to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned laparoscopic hysterectomy
- Estimated uterine weight of 500 g or more
Who cannot join
- Sexual inactivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Endoscopic Tissue Cutting and Abdominal Extraction Device With Conventional Cold Scalpel
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.
Read the detailed description
Laparoscopic surgeries are performed through incisions ranging from 0.5 cm to 1 cm in width. After the operation, masses that are much larger than these incisions need to be removed from the abdomen. The process of removing masses from the abdomen is a difficult and time-consuming process, often taking longer than the operation itself and forcing surgeons to perform open surgery. Therefore, patients are deprived of the comfort of closed surgery and experience disadvantages such as risk of infection, pain, and staying away from work and social life for a long time. The invention allows tissues/mass that are intended to be removed from the abdomen in laparoscopic surgery and are larger in size than the incisions where the operation is performed to be removed from the abdomen through these incisions. The designed device offers a fast, easy and reliable alternative to removing tissues or masses from the abdomen, which is the most time-consuming and tiring stage of laparoscopic surgery.
Currently, removing masses from the abdomen in laparoscopic surgery;
- Cutting into pieces with a scalpel,
- Using electrical devices called morcellators that are used to cut the tissue/mass with a rotational movement and take it out of the abdomen,
- It is done by directly removing the mass from the abdomen through an incision made as large as the size of the mass.
Trying to break up large tissues/mass with a scalpel through 1.5-2 cm wide holes/incisions that limit the surgeon's field of movement is quite laborious, tiring, time-consuming and risky in terms of patient health. This process can extend the duration of the surgery by 60 to 90 minutes (Nieboer et al., 2009). In addition, the risk of injury or damage to surrounding tissues is high due to the aforementioned procedures.
In the use of morcellator disintegrating devices, there is a risk that the tissue/mass that is being removed will spread/scatter into the abdomen in small pieces due to the rotational movement in the operating principle. In operations where the morcellator device is used, if the removed tissue is malignant (cancerous), the patient is at risk of metastasis spreading to the entire abdomen. Due to the bitter experiences, the use of this device has been banned in the United States and in European Union countries, it has been required to be used in sterile bags. However, even the use of these bags cannot completely prevent the spread of tissue into the abdomen.
Another way to remove the mass from the abdomen at the end of the operation is to make a large incision in the abdomen. This incision eliminates all the advantages of laparoscopic surgery, increases the patient's pain and prolongs the hospital stay, increases the cost of the operation, creates an infection risk and therefore delays the patient's return to work/social life.
With the invention and project, the mass to be removed from the abdomen after the laparoscopic operation can be removed without an additional abdominal incision in the hysterectomy (uterus removal) surgery; In myomectomy or adnexal mass surgeries, it will be shown that it can be easily removed by cutting into pieces through a 3 cm incision made at the top of the vagina. With the designed device, the tissue/mass can be quickly and safely removed from the abdomen with repetitive movements. Since large-sized tissues/mass can be removed from the abdomen through a maximum 3 cm incision with the advantage provided by the invention, patients are protected from the possible risks of a large incision. Since the invention cuts the tissue/mass directly (does not make a rotation movement like the morcellator device) and is designed to keep the cut piece in its own chamber, there is no risk of the tissue/mass spreading into the abdomen.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Vaginal tissue morcellation with extraction device, Vaginal tissue morcellation with scalpel
- Keywords
- laparoscopic hysterectomy, morcellation, tissue extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal tissue morcellation with extraction deviceDevice
Vaginal tissue morcellation after laparoscopic hysterectomy with Endoscopic Tissue Cutting and Abdominal Extraction Device
Vaginal tissue morcellation with scalpelDevice
Vaginal tissue morcellation after laparoscopic hysterectomy with cold scalpel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Vaginal tissue morcellation with scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The change in total Female Sexual Function Index (FSFI) score between the preoperative and postoperative periods will be assessed to evaluate the impact of vaginal morcellation technique on sexual function.
The FSFI is a validated questionnaire assessing sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Total scores range from 2 to 36, with higher scores indicating better sexual function.
Measured: Baseline (within 1 week before surgery) and 6 months after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start13 Nov 2025
- Primary completion13 Sep 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Anıl Arı, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226375
- Sponsor's protocol ID
- BBAP.2023.003
- Acronym
- SOLENDO-1
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will not be shared at this stage to protect intellectual property rights related to the patented device. Deidentified data may be made available upon reasonable request after study completion
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Tissue Cutting and Abdominal Extraction Device With Conventional Cold Scalpel
- ClinicalTrials.gov ID
- NCT07226375
- Acronym / sponsor ID
- SOLENDO-1 / BBAP.2023.003
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- laparoscopic hysterectomy, morcellation, tissue extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 13 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laparoscopic surgeries are performed through incisions ranging from 0.5 cm to 1 cm in width. After the operation, masses that are much larger than these incisions need to be removed from the abdomen. The process of removing masses from the abdomen is a difficult and time-consuming process, often taking longer than the operation itself and forcing surgeons to perform open surgery. Therefore, patients are deprived of the comfort of closed surgery and experience disadvantages such as risk of infection, pain, and staying away from work and social life for a long time. The invention allows tissues/mass that are intended to be removed from the abdomen in laparoscopic surgery and are larger in size than the incisions where the operation is performed to be removed from the abdomen through these incisions. The designed device offers a fast, easy and reliable alternative to removing tissues or masses from the abdomen, which is the most time-consuming and tiring stage of laparoscopic surgery.
Currently, removing masses from the abdomen in laparoscopic surgery;
- Cutting into pieces with a scalpel,
- Using electrical devices called morcellators that are used to cut the tissue/mass with a rotational movement and take it out of the abdomen,
- It is done by directly removing the mass from the abdomen through an incision made as large as the size of the mass.
Trying to break up large tissues/mass with a scalpel through 1.5-2 cm wide holes/incisions that limit the surgeon's field of movement is quite laborious, tiring, time-consuming and risky in terms of patient health. This process can extend the duration of the surgery by 60 to 90 minutes (Nieboer et al., 2009). In addition, the risk of injury or damage to surrounding tissues is high due to the aforementioned procedures.
In the use of morcellator disintegrating devices, there is a risk that the tissue/mass that is being removed will spread/scatter into the abdomen in small pieces due to the rotational movement in the operating principle. In operations where the morcellator device is used, if the removed tissue is malignant (cancerous), the patient is at risk of metastasis spreading to the entire abdomen. Due to the bitter experiences, the use of this device has been banned in the United States and in European Union countries, it has been required to be used in sterile bags. However, even the use of these bags cannot completely prevent the spread of tissue into the abdomen.
Another way to remove the mass from the abdomen at the end of the operation is to make a large incision in the abdomen. This incision eliminates all the advantages of laparoscopic surgery, increases the patient's pain and prolongs the hospital stay, increases the cost of the operation, creates an infection risk and therefore delays the patient's return to work/social life.
With the invention and project, the mass to be removed from the abdomen after the laparoscopic operation can be removed without an additional abdominal incision in the hysterectomy (uterus removal) surgery; In myomectomy or adnexal mass surgeries, it will be shown that it can be easily removed by cutting into pieces through a 3 cm incision made at the top of the vagina. With the designed device, the tissue/mass can be quickly and safely removed from the abdomen with repetitive movements. Since large-sized tissues/mass can be removed from the abdomen through a maximum 3 cm incision with the advantage provided by the invention, patients are protected from the possible risks of a large incision. Since the invention cuts the tissue/mass directly (does not make a rotation movement like the morcellator device) and is designed to keep the cut piece in its own chamber, there is no risk of the tissue/mass spreading into the abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Tissue Cutting and Abdominal Extraction Device | Experimental | Device: Vaginal tissue morcellation with extraction deviceIn the cases included in the group, vaginal morcellation will be performed with an endoscopic tissue cutting and removal device after laparoscopic hysterectomy. |
| Conventional Cold Scalpel | Active comparator | Device: Vaginal tissue morcellation with scalpelIn the cases included in the group, vaginal morcellation will be performed with a cold scalpel after laparoscopic hysterectomy. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned laparoscopic hysterectomy
- Estimated uterine weight of 500 g or more
Key exclusion criteria (1 listed)
- Sexual inactivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal tissue morcellation with extraction deviceVaginal tissue morcellation after laparoscopic hysterectomy with Endoscopic Tissue Cutting and Abdominal Extraction Device | Device | Endoscopic Tissue Cutting and Abdominal Extraction Device |
| Vaginal tissue morcellation with scalpelVaginal tissue morcellation after laparoscopic hysterectomy with cold scalpel | Device | Conventional Cold Scalpel |
Primary outcome
Morcellation Time
Time frame: From placement of uterus in retrieval bag to complete removal of specimen, measured in minutes (approximately 0-30 minutes).
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.
1 secondary outcome
Change in Female Sexual Function Index (FSFI) Score
Time frame: Baseline (within 1 week before surgery) and 6 months after operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Data will not be shared at this stage to protect intellectual property rights related to the patented device. Deidentified data may be made available upon reasonable request after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal tissue morcellation with extraction device and Vaginal tissue morcellation with scalpel in people with Laparoscopic Hysterectomy, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morcellation Time (time frame: From placement of uterus in retrieval bag to complete removal of specimen, measured in minutes (approximately 0-30 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.