- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05321134
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a single center, prospective, open-label, investigator initiated, non-randomized, interventional case-control study where researchers will study colorectal surgical procedures done using the novel Single Port (SP) Robotic Platform and compare perioperative outcomes to colorectal surgical cases done using the traditional Multi-port (Xi) Robotic Platform.
AIM 1 To assess the feasibility and safety/quality of a SP platform for transabdominal and transanal colorectal operations which are currently done using multiport robotic platforms.
AIM 2 To evaluate safety and quality outcomes post SP surgery in comparison with contemporaneous standard multiport Xi platform procedures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ankit Sarin, MD
- Phone Number: 4158853625
- Email: ankit.sarin@ucsf.edu
Study Contact Backup
- Name: Hueylan Chern, MD
- Phone Number: 4158853625
- Email: Hueylan.Chern@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- Recruiting
- UCSF Medical Center at Mission Bay
-
Contact:
- Ankit Sarin, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months prior to use of study product. To be considered to be not of childbearing potential, the subject must be postmenopausal for at least 2 years; have had a hysterectomy or bilateral tubal ligation, or be proven to be otherwise incapable of pregnancy. If of childbearing potential, the subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry and agree to continue practicing it during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spouse/partner sterility; or is practicing abstinence and agrees to continue abstinence or to start an acceptable method of contraception from the above list if sexual activity commences.
- There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.
- For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous adenomas, and localized neuroendocrine tumors) distal to 15 cm from the anal verge.
- The subject is in good general health as evidenced by medical history and physical examination
- The subject is able and willing to provide written informed consent.
- The subject agrees to comply with the requirements of the protocol and complete study measures.
- The subject has stable residence and telephone.
Exclusion Criteria:
- The subject is child less than 18 years of age
- The subject is a female who is pregnant or lactating
- The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).
- The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)
- The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the investigator precludes participation.
- The subject has advanced/ Stage IV cancer
- The subject has received neo-adjuvant chemotherapy or radiation therapy
- The subject requires an emergency operation.
- The subject is unable to fully comprehend or consent to the study
- The subject is unwilling to be available for follow-up assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Port Robotic Surgery Arm
Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system
|
After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System). Using standardized case report forms, the investigators will track clinical parameters and describe the safety & quality event rate for SP platform transabdominal and transanal colorectal operations. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess safety & quality event rate for SP platform transabdominal and transanal colorectal operations
Time Frame: 30 days
|
A safety & quality event will be defined as occurring if any of the following occur:
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ankit Sarin, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3637342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Disorders
-
Gulhane School of MedicineUniversity Hospital, Ghent; Szeged University; University Clinical Centre of... and other collaboratorsCompletedColorectal Disorders | Colorectal SurgeryTurkey
-
Institut Paoli-CalmettesNot yet recruitingColorectal Disorders
-
Leonardo Bustamante-LopezRodrigo Ambar PintoUnknownColorectal DisordersBrazil
-
Katherine DeansSociety of University SurgeonsCompleted
-
Mayo ClinicCompleted
-
Joanne TurnerRecruitingColorectal DisordersUnited Kingdom
-
Mount Sinai Hospital, CanadaRecruiting
-
Hospital Universitario La FeUnknown
-
Barts & The London NHS TrustCompletedColorectal DisordersUnited Kingdom
-
Sunnybrook Health Sciences CentreCancer Care OntarioCompletedColorectal Disorders
Clinical Trials on Single port robotic colorectal surgical procedure
-
Marks Colorectal Surgical AssociatesUnknownInflammatory Bowel Diseases | Rectal Cancer | Diverticulitis | Colon Cancer | Colon Polyp | Rectal Polyp | Prolapse, RectalUnited States
-
University of Illinois at ChicagoCompletedPediatric Robotic SurgeryUnited States
-
University of Illinois at ChicagoNot yet recruitingProstate Hyperplasia
-
Ruijin HospitalRecruiting
-
Chinese University of Hong KongCompletedUrologic Neoplasms | Urologic Diseases | Nasopharyngeal Neoplasms | Colorectal Neoplasms | Oropharyngeal Neoplasms | Hypopharyngeal Neoplasms | Laryngeal Neoplasms | Oral Neoplasms | ENT DiseasesChina
-
Asan Medical CenterCompletedEndometrial CancerKorea, Republic of
-
Korea University Guro HospitalNot yet recruitingLung Cancer | Robotics
-
Chang Gung Memorial HospitalIntuitive SurgicalRecruitingColorectal NeoplasmsTaiwan
-
Case Comprehensive Cancer CenterNot yet recruitingProstate Cancer | Prostate Adenocarcinoma
-
Ruijin HospitalIntuitive SurgicalRecruitingThoracic Surgery | da Vinci SP Surgical SystemChina