NCT06926374Toboroz
Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Gastrointestinal and Urologic Surgery
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 16. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2025. ápr. 7.
- Kezdés
- 2025. márc. 25.
- Elsődleges befejezés
- 2027. ápr.
- Fő szponzor
- Chinese University of Hong Kong
- Betegségek
- Vastagbélrák, Prosztatarák, Hólyagrák, Vesedaganat, Gyomor- és nyelőcsőrák
- NCT-szám
- NCT06926374
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 90
- 2025. márc. 25. és az elsődleges befejezés (2027. ápr.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Robotic Transanal Total Mesorectal Excision
- T4 tumor or involvement of circumferential resection margin even after neoadjuvant therapy
- Tumor requiring multivisceral resection
- Tumor requiring abdominoperineal resection; recurrent rectal tumor
- Extensive previous abdominal surgery
- Robotic Rectopexy
- Extensive previous abdominal surgery precluding minimally invasive surgery
- Radical Prostatectomy
- Previous history of prostate surgery (e.g., transurethral resection of prostate)
- Total or Partial Nephrectomy
- Previous ipsilateral kidney surgery
- Previous history of laparotomy precluding minimally invasive surgery
- Robotic Gastrectomy
- Previous history of laparotomy precluding minimally invasive surgery
- Robotic Esophagectomy
- Previous history of abdominal surgery
Egyéb
- T4 tumor
- Recurrent tumor
- T1 tumor that can be treated by local excision
- Complex kidney anatomy (e.g., horseshoe kidney, complex renal vascular anatomy)
- Radical Cystectomy
- Esophageal carcinoma after definitive chemoradiotherapy and indicated for salvage esophagectomy
- Robotic Cholecystectomy
- Acute cholecystitis
Kiket keres a vizsgálat
- Adenocarcinoma or large adenoma (not amenable to endoscopic removal) located at the colorectum (from the cecum to the anal verge) amenable to minimally invasive surgery
- Mid/low rectal adenocarcinoma located <12 cm from the anal verge
- Clinically diagnosed with previously untreated and uncomplicated rectal prolapse or enterocele
- Clinically diagnosed with nonmetastatic adenocarcinoma of prostate
- Clinically diagnosed with nonmetastatic kidney cancer
- Clinically diagnosed with nonmetastatic bladder cancer
- Robotic Esophageal Hiatal Surgery and Fundoplication
- Clinically diagnosed with Hiatal Hernia and / or Gastroesophageal reflux disease amendable to fundoplication
- Clinical diagnosis of gastric tumor (Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)) amendable to minimally invasive radical gastrectomy
- Clinical diagnosis of carcinoma of esophagus amendable to minimally invasive esophagectomy
- Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy
A regiszterben nem jelölt feltételek
- General Inclusion Criteria for All Procedures:
- Body mass index <35 kg/m2
- Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
- Willingness to participate as demonstrated by giving informed consent
- General Exclusion Criteria for All Procedures:
- Contraindication to general anesthesia
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
- Noncorrectable coagulopathy
- Presence of another malignancy or distant metastasis
- Emergency surgery
- Vulnerable population (e.g., mentally disabled, pregnancy)
- Robotic Colorectal Resection
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Prince of Wales Hospital, The Chinese University of Hong Kong | Hong Kong | Kína | Toboroz |
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