Objective The aim of this study was to provide an interim safety analysis of the first 30 surgical procedures performed using the Versius Surgical System. Background Robot-assisted laparoscopy has been developed to overcome some of the important limitations of conventional laparoscopy. The new system is currently undergoing a first-in-human prospective clinical trial to confirm the safety and effectiveness of the device when performing minimal access surgery (MAS). Methods Procedures were performed using Versius by a lead surgeon supported by an operating room (OR) team. Male or female patients aged between 18 and 65 years old and requiring elective minor or intermediate gynaecological or general surgical procedures were enrolled. The primary endpoint was the rate of unplanned conversion of procedures to other MAS or open surgery. Results The procedures included nine cholecystectomies, six robot-assisted total laparoscopic hysterectomies, four appendectomies, five diagnostic laparoscopy cases, two oophorectomies, two fallopian tube recanalisation procedures, an ovarian cystectomy and a salpingo-oophorectomy procedure. All procedures were completed successfully without the need for conversion to MAS or open surgery. No patient returned to the OR within 24 h of surgery and readmittance rate at 30 and 90 days post-surgery was 1/30 (3.3%) and 2/30 (6.7%), respectively. Conclusions This first-in-human interim safety analysis demonstrates that the Versius Surgical System is safe and can be used to successfully perform minor or intermediate gynaecological and general surgery procedures. The cases presented here provide evidence that the Versius clinical trial can continue to extend recruitment and begin to include major procedures, in alignment with the IDEAL-D Framework Stage 2b: Exploration.

BackgroundA phase I randomised, controlled, single blind, dose escalation trial was conducted to evaluate safety and immunogenicity of JAIVAC-1, a recombinant blood stage vaccine candidate against Plasmodium falciparum malaria, composed of a physical mixture of two recombinant proteins, PfMSP-119, the 19 kD conserved, C-terminal region of PfMSP-1 and PfF2 the receptor-binding F2 domain of EBA175.MethodHealthy malaria naïve Indian male subjects aged 18–45 years were recruited from the volunteer database of study site. Fifteen subjects in each cohort, randomised in a ratio of 2:1 and meeting the protocol specific eligibility criteria, were vaccinated either with three doses (10μg, 25μg and 50μg of each antigen) of JAIVAC-1 formulated with adjuvant Montanide ISA 720 or with standard dosage of Hepatitis B vaccine. Each subject received the assigned vaccine in the deltoid muscle of the upper arms on Day 0, Day 28 and Day 180.ResultsJAIVAC-1 was well tolerated and no serious adverse event was observed. All JAIVAC-1 subjects sero-converted for PfF2 but elicited poor immune response to PfMSP-119. Dose-response relationship was observed between vaccine dose of PfF2 and antibody response. The antibodies against PfF2 were predominantly of IgG1 and IgG3 isotype. Sera from JAIVAC-1 subjects reacted with late schizonts in a punctate pattern in immunofluorescence assays. Purified IgG from JAIVAC-1 sera displayed significant growth inhibitory activity against Plasmodium falciparum CAMP strain.ConclusionAntigen PfF2 should be retained as a component of a recombinant malaria vaccine but PfMSP-119 construct needs to be optimised to improve its immunogenicity.Trial RegistrationClinical Trial Registry, India CTRI/2010/091/000301

Supplemental features for educational videos; 3) Differences between high and low quality surgical videos; 4) Barriers to viewing video prior to surgery. Individual qualitative interviews were transcribed verbatim, coded and analyzed by two independent reviewers using NVivo12 Pro. RESULTS: Eighteen residents participated in qualitative interviews with 12 (67%) senior level residents (post-graduate year 3 or 4) and 6 (33%) junior level residents (post-graduate year 1 or 2). All residents had completed 10 or less vaginal hysterectomies at the time of the interviews. Gynecology residents characterized high-yield vaginal hysterectomy videos as short, accessible surgical videos available on mobile applications (Figure 1). Residents desired videos that highlight and provide insight into challenging techniques: anterior peritoneal entry, uterosacral pedicles and vaginal cuff closure. With regards to desired supplemental material, senior level residents identified intraoperative complications and troubleshooting as important whereas junior level residents identified instrumentation and anatomy review. Trainees described high quality videos as those with adequate visualization, graphics to demarcate anatomy overlaid on the dissection, review of challenging techniques and descriptive audio. Low quality videos were described as long duration, poor visualization and inadequate audio explanation. Resident awareness and video accessibility were common barriers that prevented residents from viewing vaginal hysterectomy videos prior to surgery. The importance of an accessible mobile application with short, descriptive videos were congruent across all resident experience levels. CONCLUSION: Gynecology residents desire short, app-based vaginal hysterectomy videos that are easily accessible. Understanding residents' perspective can aid educators to create videos directed toward resident learning preferences.

Introduction This study aimed to demonstrate the safe and effective use of the Versius surgical system (CMR Surgical, Cambridge, UK) in robot‐assisted total laparoscopic hysterectomy. This surgical robot was developed iteratively with input from surgeons to improve surgical outcomes and end‐user experience. We report data from the gynecology cohort of an early clinical trial designed in broad alignment with IDEAL‐D (Idea, Development, Exploration, Assessment, Long‐term follow‐up – Devices) stage 2b (Exploration). Material and methods The study is registered in the Indian clinical trials register (CTRI/2019/02/017872). Adult women requiring total hysterectomy who provided informed consent and met the eligibility criteria underwent procedures at one of three hospitals in India. Five surgeons performed robot‐assisted total laparoscopic hysterectomies using the device from March 2019 to September 2020. The primary endpoint was rate of unplanned conversion to conventional laparoscopic or open surgery. Adverse events were adjudicated by an independent clinical events committee using endoscope video recordings and clinical notes. Results In total, 144 women underwent surgery (median age: 44 years [range: 28–78]; median body mass index 25.8 kg/m2 [range: 14.3–47.8]). The rate of unplanned conversion to conventional laparoscopy was 2/144 (1.4%); neither conversion was device related. No surgery was converted to open. In total, 13 adverse events occurred among seven (4.9%) patients, comprising seven serious adverse events and six adverse events. One serious adverse event was deemed device‐related. Two patients were readmitted to hospital within 30 days; both made a full recovery. No patients died within 90 days of surgery. Conclusions The device provides a safe and effective option for total laparoscopic hysterectomy; these findings support its continued implementation in larger patient cohorts and expansion in other major minimal access indications.

Objective To find out whether maternal serum screening for fetal chromosomal aneuploidy predicts adverse pregnancy outcomes. Methods A two-year retrospective case-control study was conducted at a tertiary hospital. Pregnant women with a high-risk serum screen but with chromosomally normal fetuses (n = 189) were compared to those with low-risk screen (controls, n = 157) for adverse pregnancy outcomes. p \ 0.005) and gestational age (R 2 = 4.9 %, b ± SE = 0.613 ± 0.296; p \ 0.05). Beta hCG in first and hCG in second trimester predicted oligohydramnios (R 2 = 9.2 %, b ± SE = -0.077 ± 0.025; p \ 0.005). The areas under the ROC curves of PAPP-A for LBW and PT were 0.70(p \ 0.01) and 0.684 (p \ 0.05), respectively. Conclusion A ''high-risk'' maternal serum screen with abnormal PAPP-A and/or beta hCG/HCG is associated with adverse pregnancy outcomes and may help identifying women requiring additional fetal surveillance.