Gynecological Surgery, General Surgery, Thoracic Surgery
Conditions
Interventions
Experimental Group:The clinical trial design is prospective, multicenter, and targets a Single Group Target Value, utilizing the AGIBOT Endoscopic Surgical Robot developed by Agibot Medtech (Suzhou)
Sponsors
SIR Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Gynecological inclusion Criteria (Participants in this clinical trial must meet all of the following inclusion criteria to be enrolled in this trial) (1) 18~80 years old (inclusive), gender is not limited; (2) BMI: 18-30 kg/m2 (3) There are indications related to gynecological surgery, and the physiological condition can accept endoscopic surgery; (4) Voluntarily participate in this clinical trial, be willing to cooperate with and complete the trial follow-up and relevant examinations, and sign the subject informed consent. General Surgery Admission Criteria (Participants in this clinical trial must meet all of the following admission criteria to be enrolled in this trial) (1) 18~80 years old (inclusive), gender is not limited; (2) BMI: 18-30 kg/m2 (3) There are indications related to general surgery, and the physiological condition can accept endoscopic surgery; (4) Voluntarily participate in this clinical trial, be willing to cooperate with and complete the trial follow-up and relevant examinations, and sign the subject informed consent. Thoracic Surgery Admission Criteria (Participants in this clinical trial must meet all of the following admission criteria to be enrolled in this trial) (1) 18~80 years old (inclusive), gender is not limited; (2) BMI: 18-30 kg/m2 (3) There are indications related to thoracic surgery, and the physiological condition can accept endoscopic surgery; (4) Voluntarily participate in this clinical trial, be willing to cooperate with and complete the trial follow-up and relevant examinations, and sign the subject informed consent.
Exclusion criteria
Exclusion criteria: Gynecological exclusion criteria (Participants in this clinical trial who meet any of the following exclusion criteria will not be enrolled in this trial) (1) Patients with abdominal infection, peritonitis, serious abdominal adhesion, massive fluid accumulation in the abdominal cavity, not suitable for endoscopic surgery; (2) The lesion site infiltrates the surrounding tissues and organs, and the scope of surgery needs to be expanded or remote metastasis occurs; (3) Patients who need emergency surgery due to changes in their condition; (4) severe coagulation dysfunction, obvious bleeding tendency; (5) severe comorbidities, unable to tolerate surgery or anesthesia; (6) Pregnant or lactating women, who have reproductive needs; (7) Participating in other investigational drug or device clinical trials not completed; (8) Participants considered inappropriate to participate in this clinical trial. General surgery exclusion Criteria (Participants in this clinical trial who meet any of the following exclusion criteria will not be enrolled in this trial) (1) Patients with a history of endoscopic or open surgery at the proposed surgical site within 1 year before signing the informed consent; (2) Patients with abdominal infection, peritonitis, diaphragmatic hernia, serious abdominal adhesion, massive fluid accumulation in the abdominal cavity, not suitable for endoscopic surgery; (3) The lesion site infiltrates the surrounding tissues and organs, and the scope of surgery needs to be expanded or remote metastasis occurs; (4) Patients who need emergency surgery due to changes in their condition; (5) severe coagulation dysfunction, obvious bleeding tendency; (6) Severe comorbidities, unable to tolerate surgery or anesthesia; (7) Pregnant or lactating women; (8) Participating in other investigational drug or device clinical trials not completed; (9) Participants considered inappropriate to participate in this clinical trial. Thoracic surgery exclusion Criteria (Participants in this clinical trial who meet any of the following exclusion criteria will not be enrolled in this trial) (1) Patients with a history of endoscopic or open surgery at the proposed surgical site within 1 year before signing the informed consent; (2) Patients with pulmonary tuberculosis, pulmonary infection, severe thoracic adhesion, and massive pleural effusion, who are not suitable for endoscopic surgery; (3) The lesion site infiltrates the surrounding tissues and organs, and the scope of surgery needs to be expanded or remote metastasis occurs; (4) Patients who need emergency surgery due to changes in their condition; (5) severe coagulation dysfunction, obvious bleeding tendency; (6) Severe comorbidities, unable to tolerate surgery or anesthesia; (7) Pregnant or lactating women; (8) Participating in other investigational drug or device clinical trials not completed; (9) Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-Conversion Rate;Incidence of Device-Related or Possibly Device-Related Complications Meeting Clavien-Dindo Grade 3 or Higher from First Incision to 30 Days Postoperative; | — |
Secondary
| Measure | Time frame |
|---|---|
| Installation Time;Operative Time;Estimated Intraoperative Blood Loss (mL);Patient Pain Score;Transfusion Rate;Postoperative Hospital Stay;Number of Lymph Nodes Dissected;Postoperative Drain Removal Time;Postoperative Flatulence Time;Pulmonary Function (Specific to Thoracic Surgery);Positive Resection Margin Rate;Overall Complication Rate from First Incision to 30 Days Postoperative (Clavien-Dindo Grade 1 or Higher);30-Day Readmission RatReoperation RateMortality Rate;Surgeon Satisfaction Rating; | — |
Countries
China
Contacts
Public ContactXiujun Cai
SIR Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed