NCT05457244Active, not recruiting
Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option. All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jun 2022
- Start date
- 1 Sept 2023
- Primary completion date
- 19 Jun 2024
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05457244
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Sept 2023 to the primary completion date, 19 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery
- Previous laparotomy history
Other illness
- Patient has metastatic disease
- Patient has a bleeding or clotting disorder
- Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements
Other
- Patient unable to provide informed consent
- Patient is pregnant
- BMI 35.0 or higher
Who the study is looking for
- Age ≥18 years
- Pathological confirm of colon or rectal cancer
- Clinical stage I-III
- Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.
- ASA ≤3
- Performance status: ECOG 0-1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.