Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314

Berducci, Martin; Fuchs, Hans; Omelanczuk, Pablo; Broderick, Ryan C.; Harnsberger, Cristina R.; Langert, Joshua; Nefa, Jorge; Jaureguiberry, Pablo; Gomez, Pablo; Miranda, Laura; Jacobsen, Garth R.; Sandler, Bryan J.; Horgan, Santiago

doi:10.1007/s00464-015-4319-2

Cited by 15 publications

(7 citation statements)

References 24 publications

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“…In our previous studies, we demonstrated the feasibility of surgical procedures using the SymphonX platform [3,4,11]. This study now addresses, how laparoscopic novices, medical students without any laparoscopic experience, are able to deal with the new device.…”

Section: Discussionmentioning

confidence: 93%

“…Since its introduction to clinical practice laparoscopic surgery underwent an enormous development [1,2]. The pathway of minimally invasive surgery until the most recent milestones such as single-port and robotic surgery has been reported before [3][4][5][6][7][8][9][10][11][12]. In this context, we recently described our first preclinical experience with a newly developed single-port device, fitting through a standard 15-mm trocar [3,4].…”

mentioning

confidence: 99%

“…The pathway of minimally invasive surgery until the most recent milestones such as single-port and robotic surgery has been reported before [3][4][5][6][7][8][9][10][11][12]. In this context, we recently described our first preclinical experience with a newly developed single-port device, fitting through a standard 15-mm trocar [3,4]. More recently, we were able to demonstrate the feasibility of true single-port surgery using the in the meantime certified "SymphonX platform" performing the first clinical series of laparoscopic cholecystectomy through only one 15-mm trocar without any assisting instruments [11].…”

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confidence: 99%

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Learning curve of surgical novices using the single-port platform SymphonX: minimizing OR trauma to only one 15-mm incision

et al. 2020

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Background Minimally invasive single-port surgery is always associated with large incisions up to 2–3 cm, complicated handling due to the lack of triangulation, and instrument crossing. The aim of this prospective study was to report how medical students without any laparoscopic experience perform several laparoscopic tasks (rope pass, paper cut, peg transfer, recapping, and needle threading) with the new SymphonX single-port platform and to examine the learning curves in comparison to the laparoscopic multi-port technique. Methods A set of 5 laparoscopic skill tests (Rope Pass, Paper cut, Peg Transfer, Recapping, Needle Thread) were performed with 3 repetitions. Medical students performed all tests with both standard laparoscopic instruments and the new platform. Time and errors were recorded. Results A total of 114 medical students (61 females) with a median age of 23 years completed the study. All subjects were able to perform the skill tests with both standard laparoscopic multi-port and the single-port laparoscopic system and were able to significantly improve their performance over the three trials for all five tasks—rope pass (p < 0.001), paper cut (p < 0.001), peg transfer (p < 0.001), needle threading (p < 0.001), and recapping (p < 0.001). In 3 out of 5 tasks, medical students performed the tasks faster using the standard multi-port system—rope pass (p < 0.001), paper cut (p < 0.001), and peg transfer (p < 0.001). In the task recapping, medical students performed the task faster using the new single-port system (p = 0.003). In the task needle threading, there was no significant difference between the standard multi-port system and the new single-port system (p > 0.05). Conclusion This is the first study analyzing learning curves of the commercially available SymphonX platform for abdominal laparoscopic surgery when used by novices. The learning curve and the error rate are promising.

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Section: Discussionmentioning

confidence: 93%

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confidence: 99%

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confidence: 99%

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Learning curve of surgical novices using the single-port platform SymphonX: minimizing OR trauma to only one 15-mm incision

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“…Our group focused on developing an endoscopic suturing-technique using a standard flexible endoscope and the newly designed, flexible, articulating instrument (EndoSuture, Fortimedix-Surgical BV, Geleen, Netherlands) allowing for complex end-effector movements [12,13]. Initially we set up prerequisites.…”

Section: Methodsmentioning

confidence: 99%

New Suturing System for Flexible Endoscopy in The Gastrointestinal Tract

Kh¹,

Neki²,

Lee³

et al. 2021

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1.1. Background: We have assessed an approach, enabling an endoscopist together with surgical assistance to perform endoscopic sutures based on minimally-invasive principles. Aim:Assessment of a new suturing-system in the gastrointestinal tract. Methods:An endoscopist and a surgical assistant used a standard flexible scope and an external 5mm needle-holder with a flexible shaft and articulating end-effectors to perform sutures within the esophagus. For knot-tying, a 5mm flexible knot-pusher was used. The procedures were performed by 4 surgeons with different levels of experience. Assessment of this system consisted of initial box-testing in explants and subsequently in a porcine model to explore different prototypes of needle-holder, suture-materials and time-consumption with suturing. In the final series duration of closure of an esophageal incision was measured. Results:Results show a good feasibility with a mean duration for single bite suturing of 10 min (8-35) and extracorporeal knot-tying median duration 5 min (2-8). The closure of an esophageal incision required a double bite procedure, followed by 3 knots in a median time of 20 min (14-45), performed by 4 endoscopists/surgeons of different level of experience. Conclusion:In animal studies we established the feasibility of a new flexible articulating instruments with flexible endoscopy and surgical assistance to perform reliable intraluminal sutures.

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“…Here, we investigate a novel minimally invasive surgical platform for its utility in the transoral approach to the oropharynx, hypopharynx, and larynx. The Fortimedix Surgical B.V. symphonX™ single-port surgical platform is FDA approved for minimally invasive abdominal laparoscopic surgery and has been described for use in laparoscopic cholecystectomy [ 14 , 15 ]. This platform has been adapted from a single-port laparoscopic device and modified to allow introduction via a surgical laryngoscope for use in the transoral approach to the upper aerodigestive tract.…”

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Preclinical experience with a novel single-port platform for transoral surgery

et al. 2021

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Background We investigated a novel minimally invasive surgical platform for use in the oropharynx, hypopharynx, and larynx for single-port transoral surgery used in concert with standard transoral laryngeal and pharyngeal instrumentation. Methods The preclinical investigational device by Fortimedix Surgical B.V. (Netherlands) features two channels for manually controlled flexible articulating surgical instruments. A third central channel accepts both rigid and flexible endoscopes. The system is coupled to a standard laryngoscope for transoral access. In three cadaver models, we evaluated the surgical capabilities using wristed grasping instruments, microlaryngeal scissors, monopolar cautery, and a laser fiber sheath. Procedures were performed within the oropharynx, supraglottis, glottis, subglottis, and hypopharynx. Results Within the oropharynx, we found adequate strength, range of motion, and dexterity to perform lateral oropharyngectomy and tongue base resection. Within the larynx, visualization was achieved with a variety of instruments including a flexible, 0° and 30° rigid endoscope. The glottis, supraglottis, pyriform sinuses, post-cricoid space, and esophageal inlet were readily accessible. Visualization and manipulation of grasping, laser, and monopolar cautery instruments were also possible within the subglottis. Instrument reach and accuracy facilitated completion of a delicate micro-flap on the true vocal fold. Other procedures included vocal fold resection, cricopharyngeal myotomy, and resection of subglottic mucosa. Conclusions From this initial proof of concept experience with this novel platform, we found a wide range of procedures within the oropharynx, larynx, and hypopharynx to be feasible. Further work is needed to evaluate its applicability to the clinical setting. The ability of this platform to be used with conventional instrumentation may provide an opportunity for complex transoral surgery to be performed in a facile manner at greatly reduced cost.

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Phase II clinical experience and long-term follow-up using the next-generation single-incision platform FMX314

Abstract: This study demonstrates that single-incision cholecystectomy with the platform is feasible, safe, and reproducible in a larger patient population. Long-term follow-up showed no hernias or other adverse events. Further studies will be needed to evaluate longer-term hernia rates.

Cited by 15 publications

References 24 publications

Learning curve of surgical novices using the single-port platform SymphonX: minimizing OR trauma to only one 15-mm incision

Learning curve of surgical novices using the single-port platform SymphonX: minimizing OR trauma to only one 15-mm incision

New Suturing System for Flexible Endoscopy in The Gastrointestinal Tract

Preclinical experience with a novel single-port platform for transoral surgery

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