Health TrialsbyHealthPanel

Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

ConditionRobotic Assisted Inguinal Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorCMR Surgical Ltd

About this trial

The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.

Patients providing written informed consent to participate in the study.

Disqualifiers

Patient unwilling to provide informed consent.

Medical contraindication for general anaesthesia or minimally invasive procedure.

Patient participation in an interventional clinical study that could impact primary outcomes results.

Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above.

Trial design

Design model

Single group

Treatments tested in this trial

  • Versius Surgical System

    Device

    Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Surgery with VersiusExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success rate

Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery

Time frame
Up to completion of surgery
2

Serious Adverse Event rate

Rate of total procedure related serious adverse events

Time frame
Up to 30 days post procedure

Secondary outcomes

1

Operative time

Surgical time from skin incision to skin closure

Time frame
Up to completion of surgery
2

Estimated blood loss

Amount of blood estimated to be lost during surgery (in mL)

Time frame
Up to completion of surgery
3

Intra-operative adverse events

Adverse events that occur during surgery

Time frame
Up to completion of surgery
4

Blood transfusion

Need for blood transfusion during surgery as well as amount transfused

Time frame
Up to completion of surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CMR Surgical Ltd

Lead sponsor

Hospital Universitari de Bellvitge

Collaborator

Niguarda Hospital

Collaborator

Source ClinicalTrials.gov
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