Rectal NeoplasmsNCT07522294
Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
A study testing da Vinci SP Surgical System in people with Rectal Neoplasms and Rectal Cancer Patients, run by Jeng-Fu You at 1 site in Taiwan.
Trial summary
Title Case Summary: "This study evaluates the safety, feasibility, and short-term clinical outcomes of a new surgical approach called Single-Port (SP) Robotic Transanal Minimally Invasive Surgery (SPR TAMIS) for treating rectal tumors." Content: Transanal Minimally Invasive Surgery (TAMIS) is a standard technique for… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Neoplasms, Rectal Cancer Patients, Rectal Benign Lesions
- What is being tested?
- da Vinci SP Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with benign rectal lesions, including large adenomas or polyps not amenable to standard endoscopic removal
- Patients with recurrent or residual rectal lesions following incomplete endoscopic resection
- Patients with early-stage rectal cancer (clinical T1 tumors confined to the submucosa) with favorable histologic features (e.g., well-differentiated, no lymphovascular or perineural invasion)
- Select patients with T2 rectal cancer who are medically unfit for radical surgery or require local palliation
- Patients with clinically downstaged rectal cancer (e.g., cT0 or near-complete response) following neoadjuvant chemoradiotherapy, in whom TAMIS may be used for local excision to confirm pathological response
Who cannot join
- Patients undergoing excision of rectal neuroendocrine tumors
- Patients with bulky tumors or advanced disease (clinical T3-T4)
- Patients with radiologic or clinical evidence of nodal involvement
- Patients with high-risk histologic features (e.g., lymphovascular invasion, perineural invasion, poor differentiation), unless TAMIS is performed for palliative purposes or in patients unfit for radical surgery
- Patients in whom completion radical surgery is clearly indicated based on preoperative assessment
Trial locations and contacts
1 site in 1 country.
About this study
Title Case Summary: "This study evaluates the safety, feasibility, and short-term clinical outcomes of a new surgical approach called Single-Port (SP) Robotic Transanal Minimally Invasive Surgery (SPR TAMIS) for treating rectal tumors."
Content:
Read more
Transanal Minimally Invasive Surgery (TAMIS) is a standard technique for treating early-stage rectal tumors. However, traditional TAMIS often faces challenges such as restricted vision and instrument crowding in the narrow rectum.
The purpose of this study is to establish a standardized surgical procedure using a single-port robotic platform, which provides better flexibility and visualization. The investigators will analyze real-world clinical cases and surgical videos to assess key outcomes, including the success of tumor resection (R0 resection rate), operative safety, and patient recovery parameters. The study aims to provide clinical evidence for this robotic technique and facilitate its standardized implementation in surgical practice.
Read the detailed description
Transanal Minimally Invasive Surgery (TAMIS) is a key minimally invasive technique for the treatment of early-stage rectal tumors and selected rectal lesions. It offers advantages such as organ preservation, avoidance of abdominal incisions, reduced complications, and accelerated postoperative recovery. However, conventional TAMIS procedures are often limited by instrument crowding and restricted operative vision, especially within the narrow confines of the rectum.
The single-port robotic platform provides enhanced flexibility, articulation, and visualization, offering a promising solution to the technical challenges of transanal surgery. This study aims to establish a standardized surgical protocol for SP-assisted Robotic TAMIS (SPR TAMIS) and to evaluate its clinical safety, feasibility, and short-term outcomes.
The investigators will incorporate real-world clinical cases and intraoperative videos to perform procedural decomposition, analyze key surgical steps, assess R0 resection rates, and measure recovery-related parameters. In parallel, the project will develop a dedicated educational module and performance evaluation tools to support skill transfer and broader clinical implementation.
This project is expected to facilitate the standardization of the Robotic TAMIS workflow, provide evidence for its clinical efficacy, and build a structured training platform. This project will help establish a standardized framework for robotic transanal surgery, improve patient care through precise and less invasive techniques, and foster broader clinical integration of advanced robotic platforms within Taiwan's surgical practice.
- Being tested
- da Vinci SP Surgical System
- Keywords
- TAMIS (Transanal Minimally Invasive Surgery), Robotic Surgery, Single-port Robot, SPR TAMIS, Transanal Surgery, Minimally Invasive Surgery, Natural Orifice Transluminal Endoscopic Surgery (NOTES)
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci SP Surgical SystemDevice
This intervention involves the use of a single-port robotic platform to perform transanal excision of rectal tumors. The procedure includes robotic docking, precise tumor dissection with wristed instrumentation, and robotic-assisted closure of the rectal defect.
| Study group | Role | What they receive |
|---|---|---|
| SPR TAMIS Group | Experimental | Participants with early-stage rectal tumors or lesions undergoing Transanal Minimally Invasive Surgery (TAMIS) using a single-port robotic platform. Receives: Device: da Vinci SP Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedure-Related Adverse Events
Number of participants experiencing procedure-related adverse events within 30 days after surgery, graded according to the Clavien-Dindo classification.
Measured: Within 30 days postoperatively
Secondary outcomes (1)
Number of Standardized Surgical Steps Identified
Number of discrete procedural steps defined for SPR TAMIS based on intraoperative video analysis.
Measured: Throughout the study period (Expected 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeng-Fu You
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeng-Fu You, Chang Gung Memorial Hospital
- Investigators
- JENG-FU YOU, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522294
- Sponsor's protocol ID
- 202501208A3
- Status last verified
- Apr 2026
- First submitted
- 24 Dec 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision
- ClinicalTrials.gov ID
- NCT07522294
- Acronym / sponsor ID
- 202501208A3
- Keywords
- TAMIS (Transanal Minimally Invasive Surgery), Robotic Surgery, Single-port Robot, SPR TAMIS, Transanal Surgery, Minimally Invasive Surgery, Natural Orifice Transluminal Endoscopic Surgery (NOTES)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jeng-Fu YouUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Apr 2026 (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.
Title Case Summary: "This study evaluates the safety, feasibility, and short-term clinical outcomes of a new surgical approach called Single-Port (SP) Robotic Transanal Minimally Invasive Surgery (SPR TAMIS) for treating rectal tumors."
Content:
Transanal Minimally Invasive Surgery (TAMIS) is a standard technique for treating early-stage rectal tumors. However, traditional TAMIS often faces challenges such as restricted vision and instrument crowding in the narrow rectum.
The purpose of this study is to establish a standardized surgical procedure using a single-port robotic platform, which provides better flexibility and visualization. The investigators will analyze real-world clinical cases and surgical videos to assess key outcomes, including the success of tumor resection (R0 resection rate), operative safety, and patient recovery parameters. The study aims to provide clinical evidence for this robotic technique and facilitate its standardized implementation in surgical practice.
Detailed description
Transanal Minimally Invasive Surgery (TAMIS) is a key minimally invasive technique for the treatment of early-stage rectal tumors and selected rectal lesions. It offers advantages such as organ preservation, avoidance of abdominal incisions, reduced complications, and accelerated postoperative recovery. However, conventional TAMIS procedures are often limited by instrument crowding and restricted operative vision, especially within the narrow confines of the rectum.
The single-port robotic platform provides enhanced flexibility, articulation, and visualization, offering a promising solution to the technical challenges of transanal surgery. This study aims to establish a standardized surgical protocol for SP-assisted Robotic TAMIS (SPR TAMIS) and to evaluate its clinical safety, feasibility, and short-term outcomes.
The investigators will incorporate real-world clinical cases and intraoperative videos to perform procedural decomposition, analyze key surgical steps, assess R0 resection rates, and measure recovery-related parameters. In parallel, the project will develop a dedicated educational module and performance evaluation tools to support skill transfer and broader clinical implementation.
This project is expected to facilitate the standardization of the Robotic TAMIS workflow, provide evidence for its clinical efficacy, and build a structured training platform. This project will help establish a standardized framework for robotic transanal surgery, improve patient care through precise and less invasive techniques, and foster broader clinical integration of advanced robotic platforms within Taiwan's surgical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPR TAMIS Group | Experimental | Device: da Vinci SP Surgical SystemParticipants with early-stage rectal tumors or lesions undergoing Transanal Minimally Invasive Surgery (TAMIS) using a single-port robotic platform. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with benign rectal lesions, including large adenomas or polyps not amenable to standard endoscopic removal
- Patients with recurrent or residual rectal lesions following incomplete endoscopic resection
- Patients with early-stage rectal cancer (clinical T1 tumors confined to the submucosa) with favorable histologic features (e.g., well-differentiated, no lymphovascular or perineural invasion)
- Select patients with T2 rectal cancer who are medically unfit for radical surgery or require local palliation
- Patients with clinically downstaged rectal cancer (e.g., cT0 or near-complete response) following neoadjuvant chemoradiotherapy, in whom TAMIS may be used for local excision to confirm pathological response
Key exclusion criteria (5 listed)
- Patients undergoing excision of rectal neuroendocrine tumors
- Patients with bulky tumors or advanced disease (clinical T3-T4)
- Patients with radiologic or clinical evidence of nodal involvement
- Patients with high-risk histologic features (e.g., lymphovascular invasion, perineural invasion, poor differentiation), unless TAMIS is performed for palliative purposes or in patients unfit for radical surgery
- Patients in whom completion radical surgery is clearly indicated based on preoperative assessment
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 |
|---|---|---|
| da Vinci SP Surgical SystemThis intervention involves the use of a single-port robotic platform to perform transanal excision of rectal tumors. The procedure includes robotic docking, precise tumor dissection with wristed instrumentation, and robotic-assisted closure of the rectal defect. | Device | SPR TAMIS Group |
Primary outcome
Number of Participants With Procedure-Related Adverse Events
Time frame: Within 30 days postoperatively
Number of participants experiencing procedure-related adverse events within 30 days after surgery, graded according to the Clavien-Dindo classification.
1 secondary outcome
Number of Standardized Surgical Steps Identified
Time frame: Throughout the study period (Expected 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
JENG-FU YOU study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci SP Surgical System in people with Rectal Neoplasms and Rectal Cancer Patients, run by Jeng-Fu You at 1 site in Taiwan.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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 Participants With Procedure-Related Adverse Events (time frame: Within 30 days postoperatively). 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 17 Apr 2026.