Benign Colon TumorNCT04247958
A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures
An observational study of Benign Colon Tumor and Malignant Colorectal Tumor, run by Intuitive Surgical at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Colon Tumor, Malignant Colorectal Tumor, Benign Colorectal Neoplasm
- What is being tested?
- Colorectal resection
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject undergoing robotic-assisted colorectal procedure for suspected or confirmed benign or malignant colon or rectal disease.
Who may be able to join
- The subject must be 18 years of age or older at the time of consent
- Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis
Who cannot join
- Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
- Subject with active bacterial or fungal infection
- Subject is contraindicated for general anesthesia or surgery
- Subject is undergoing an emergency procedure
- Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
- Subject has metastatic disease and/or subject has life expectancy of less than 1 year
Show all 18Show fewer
- Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure
- Subject has history of coagulation or hematologic disorder
- Pregnant or suspect pregnancy
- The subject is unable to comply with the follow-up visit schedule
- Subject has perforated, obstructing or locally invasive neoplasm (T4b)
- Subject with inflammatory bowel disease
- Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
- Intra-Operative Exclusion Criteria:
- Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler.
- Inadequate visualization making an endoscopic approach not feasible
- Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Read the detailed description
This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.
The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
- Being tested
- Colorectal resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal resectionProcedure or surgery
Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted colorectal resection | Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum. Receives: Procedure: Colorectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SureForm™ Stapler fires and reload colors
The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Measured: During the procedure
Secondary outcomes (1)
Incidence of peri-operative and short term outcomes
The secondary endpoint of the study is to assess the incidence of peri-operative and short term outcomes following transection and/or creation of anastomosis using SureForm™ Staplers during robotic-assisted colorectal procedures.
Measured: 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Jan 2020
- Primary completion21 Jul 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Colon TumorStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247958
- Sponsor's protocol ID
- ISI-dVCR-003
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures
- ClinicalTrials.gov ID
- NCT04247958
- Acronym / sponsor ID
- ISI-dVCR-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Jan 2020 (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.
The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Detailed description
This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.
The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted colorectal resection | – | Procedure: Colorectal resectionSubjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject undergoing robotic-assisted colorectal procedure for suspected or confirmed benign or malignant colon or rectal disease.
Key inclusion criteria (2 listed)
- The subject must be 18 years of age or older at the time of consent
- Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis
Key exclusion criteria (18 listed)
- Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
- Subject with active bacterial or fungal infection
- Subject is contraindicated for general anesthesia or surgery
- Subject is undergoing an emergency procedure
- Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
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 |
|---|---|---|
| Colorectal resectionRobotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis. | Procedure or surgery | Robotic-assisted colorectal resection |
Primary outcome
Number of SureForm™ Stapler fires and reload colors
Time frame: During the procedure
The primary endpoint of the study is to assess the number of fires and reload colors of SureForm™ Staplers utilized for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
1 secondary outcome
Incidence of peri-operative and short term outcomes
Time frame: 30 days post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Colon Tumor and Malignant Colorectal Tumor, run by Intuitive Surgical at 1 site in United States.
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 2 inclusion and 18 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: finished, as of the sponsor's last update on 5 Jan 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SureForm™ Stapler fires and reload colors (time frame: During the procedure). 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 5 Jan 2024.