AdenopathyNCT06828419
A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
A study testing Domestic single-port laparoscopic surgery system in people with Adenopathy and Uterine Fibroids, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Adenopathy, Uterine Fibroids, Ovarian Cysts
- What is being tested?
- Domestic single-port laparoscopic surgery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
- Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
- Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
- Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
- Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
- According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included.
Who cannot join
- Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
- Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
- Genital tract infection or in the acute phase of systemic infection;
- Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
- Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
- A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery;
- Not willing to undergo endoscopic surgery;
- Participated in other drug and device clinical trials within 3 months before surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Xingyu Yang, Master, +86 173 9805 4822, yangxy_822@163.com
Ping Duan, Master, +86 135 8743 0406, dppddpp@126.com
About this study
In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.
- Conditions
- Adenopathy, Uterine Fibroids, Ovarian Cysts, Adnexal Mass, Ovarian Diseases, Adnexal Cyst
- Being tested
- Domestic single-port laparoscopic surgery system
- Keywords
- robotic-assisted laparoscopic single-site surgery (R-LESS), single-port robot system (SPRS), day surgery
- Medical subject headings
- Lymphadenopathy, Leiomyoma, Ovarian Cysts, Ovarian Diseases, Adnexal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic single-port laparoscopic surgery systemDevice
The minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。
| Study group | Role | What they receive |
|---|---|---|
| Domestic single-port laparoscopic surgery system group | Other | The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients Receives: Device: Domestic single-port laparoscopic surgery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day Surgery Success Rate
Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.
Measured: Patient recruitment ends and all patients complete surgery, up to 2 years
Secondary outcomes (14)
Time of Operation
Time of operation includes total operation time, operator teleoperation time, robot system parking time and instrument docking time。
Measured: From pre-surgery to the end of surgery，up to 12 hours
Blood Loss Evaluation
The estimated intraoperative blood loss and the difference of hemoglobin before and after operation.
Measured: From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery
Surgeon Satisfaction Evaluation
Surgeon satisfaction questionnaire
Measured: Up to 1 day after surgery
Time of First Postoperative Anal Exhaust
time recording
Measured: Up to 2 day after surgery
First Spontaneous Urination Time
Time recording
Measured: Up to 2 day after surgery
Pain Score
Visual Analogue Scale(VAS)
Measured: 4 hours after surgery
Hospital Stays
Time
Measured: From the date of admission to the Date of discharge, assessed up to 2 days
Postoperative Rehabilitation Evaluation
Quality of Life-15(QOL-15)
Measured: Within 1 day after surgery; 24 hours and 30 days after discharge
Abdominal Incision Healing
Observation
Measured: Within 1 day after surgery
Scar Satisfaction
Scar Cosmesis Assessment and Rating(SCAR)
Measured: 30 days after discharge
Discharge Assessment
Postanesthesia Discharge Score(PADS)
Measured: Within 1 day after surgery, 4 hours after discharge
Postoperative Complication
Telephone, Wechat official account and outpatient follow-up
Measured: 4 hours, 24 hours and 30 days after discharge
Quality and Safety Evaluation of Day Surgery
13 indexes of quality and safety evaluation of day surgery
Measured: 30 days after discharge
Safety Evaluation
6 indexes of safety evaluations
Measured: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenopathyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828419
- Sponsor's protocol ID
- SAHoWMU-CR2024-07-124
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery
- ClinicalTrials.gov ID
- NCT06828419
- Acronym / sponsor ID
- SAHoWMU-CR2024-07-124
- Conditions
- Adenopathy, Uterine Fibroids, Ovarian Cysts, Adnexal Mass, Ovarian Diseases, Adnexal Cyst
- Keywords
- robotic-assisted laparoscopic single-site surgery (R-LESS), single-port robot system (SPRS), day surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Feb 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.
In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Domestic single-port laparoscopic surgery system group | Other | Device: Domestic single-port laparoscopic surgery systemThe domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2;
- Conscious, no history of mental illness, accompanied by an adult during the perioperative period;
- Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method;
- Subjects and families understand perioperative care and are willing and able to complete post-discharge care;
- Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points;
Key exclusion criteria (8 listed)
- Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system;
- Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs;
- Genital tract infection or in the acute phase of systemic infection;
- Subjects on long-term anticoagulant therapy or with coagulation dysfunction;
- Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia;
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 |
|---|---|---|
| Domestic single-port laparoscopic surgery systemThe minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。 | Device | Domestic single-port laparoscopic surgery system group |
Primary outcome
Day Surgery Success Rate
Time frame: Patient recruitment ends and all patients complete surgery, up to 2 years
Day surgery success rate means that no other operation is performed during the operation and the patient is discharged within 48 hours.
14 secondary outcomes
Time of Operation
Time frame: From pre-surgery to the end of surgery，up to 12 hours
Blood Loss Evaluation
Time frame: From the time of hemoglobin measurement before surgery to the time of hemoglobin measurement after surgery, up to 1 day after surgery
Surgeon Satisfaction Evaluation
Time frame: Up to 1 day after surgery
Time of First Postoperative Anal Exhaust
Time frame: Up to 2 day after surgery
First Spontaneous Urination Time
Time frame: Up to 2 day after surgery
Pain Score
Time frame: 4 hours after surgery
Hospital Stays
Time frame: From the date of admission to the Date of discharge, assessed up to 2 days
Postoperative Rehabilitation Evaluation
Time frame: Within 1 day after surgery; 24 hours and 30 days after discharge
Abdominal Incision Healing
Time frame: Within 1 day after surgery
Scar Satisfaction
Time frame: 30 days after discharge
Discharge Assessment
Time frame: Within 1 day after surgery, 4 hours after discharge
Postoperative Complication
Time frame: 4 hours, 24 hours and 30 days after discharge
Quality and Safety Evaluation of Day Surgery
Time frame: 30 days after discharge
Safety Evaluation
Time frame: Day of surgery and within 1 day after surgery; 4 hours, 24 hours and 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic single-port laparoscopic surgery system in people with Adenopathy and Uterine Fibroids, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingyu Yang, Master (+86 173 9805 4822, yangxy_822@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day Surgery Success Rate (time frame: Patient recruitment ends and all patients complete surgery, up to 2 years). 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 3 Apr 2025.