Clinical trial · Interventional
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery
A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery: A Prospective, Single Center, Multispecialty Study
NCT03010813CI-TRIAL-00031564completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single center, multispecialty study that aimed to evaluate the clinical feasibility and safety of single port surgery and NOTES (mainly transanal and transoral surgery) using a novel single port robotic system.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| ENT Diseases | — | UNRESOLVED | — |
| Hypopharyngeal Neoplasms | Hypopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Oral Neoplasms | Oral Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Oropharyngeal Neoplasms | Oropharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Urologic Diseases | — | UNRESOLVED | — |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic single port surgery and NOTES | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel single port robotic system
- description
- A single port innovation designed to deliver an articulating 3D high definition camera and three fully articulating instruments through a single 25-mm cannula
- interventionNames
- Procedure: Robotic single port surgery and NOTES
Primary outcomes (2)
- measure
- Conversion rate
- timeFrame
- Up to 1 month
- description
- An emergent change in the treatment plan to conventional minimally invasive (laparoscopic/endoscopic) surgery (i.e. the use of more than one additional port), multiport robotic surgery, or to open surgery
- measure
- Perioperative complications
- timeFrame
- Up to 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
GENERAL INCLUSION CRITERIA FOR ALL PROCEDURES 1. Body mass index \<35 kg/m2 2. Suitable for minimally invasive surgery 3. Willingness to participate as demonstrated by giving informed consent GENERAL EXCLUSION CRITERIA FOR ALL PROCEDURES 1. Contraindication to general anesthesia 2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention 3. Untreated active infection 4. Noncorrectable coagulopathy 5. Presence of another malignancy or distant metastasis 6. Emergency surgery 7. Vulnerable population (e.g. mentally disabled, pregnancy)
References
Publications (2)
- DERIVEDHolsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654. PMID 31536129
- DERIVEDChan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28. PMID 31178203