---
title: Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery
nct_id: NCT07316517
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: CMR Surgical Ltd
study_type: INTERVENTIONAL
primary_condition: Robotic Assisted Inguinal Hernia Repair
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07316517.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07316517"
ct_last_update_post_date: 2026-01-05
last_seen_at: "2026-05-12T06:50:02.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Versius Clinical Study in Robot Assisted Inguinal Hernia Repair Surgery

**Official Title:** Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Inguinal Hernia Repair Surgery

**NCT ID:** [NCT07316517](https://clinicaltrials.gov/study/NCT07316517)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** CMR Surgical Ltd
- **Collaborators:** Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
- **Conditions:** Robotic Assisted Inguinal Hernia Repair
- **Start Date:** 2026-03
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2026-01-05

## Brief Summary

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

## Eligibility

- **Minimum age:** 22 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.
2. Patients providing written informed consent to participate in the study.

Exclusion Criteria:

1. Patient unwilling to provide informed consent.
2. Medical contraindication for general anaesthesia or minimally invasive procedure.
3. Patient participation in an interventional clinical study that could impact primary outcomes results.
4. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above.
5. Patients undergoing a concomitant surgical procedure.
6. Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).
```

## Arms

- **Surgery with Versius** (EXPERIMENTAL)

## Interventions

- **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.

## Primary Outcomes

- **Success rate** _(time frame: Up to completion of surgery)_ — Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery
- **Serious Adverse Event rate** _(time frame: Up to 30 days post procedure)_ — Rate of total procedure related serious adverse events

## Secondary Outcomes

- **Operative time** _(time frame: Up to completion of surgery)_
- **Estimated blood loss** _(time frame: Up to completion of surgery)_
- **Intra-operative adverse events** _(time frame: Up to completion of surgery)_
- **Blood transfusion** _(time frame: Up to completion of surgery)_
- **Device deficiencies** _(time frame: Up to completion of surgery)_
- **Reoperation within 24 hours** _(time frame: 24 hours post-surgery)_
- **Length of hospital stay** _(time frame: Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)_
- **Adverse events** _(time frame: Up to 30 days post-surgery)_
- **Readmission** _(time frame: Up to 30 days post-surgery)_
- **Reoperation within 30 days** _(time frame: Up to 30 days post-surgery)_
- **Mortality rate** _(time frame: Up to 30 days post-surgery)_

## Locations (1)

- Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan, Milan, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.division of general oncologic and minimally invasive surgery, niguarda hospital milan|milan||italy` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07316517*  
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