Surgical Navigation System for Thoracic Wall Surgery

(INSPIRE Trial)

Overseen By Judy McConnell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Unresectable lesions, Metallic implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgical navigation system designed to help surgeons remove parts of the chest wall with greater precision. The main goal is to reduce the likelihood of additional surgeries by ensuring the first surgery is as accurate as possible. This trial may suit individuals scheduled for chest wall surgery who do not have metal implants, such as pacemakers, which might interfere with the technology. As an unphased trial, it offers patients the chance to contribute to innovative surgical advancements that could improve future outcomes.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this surgical navigation system is safe for thoracic wall surgery?

Research shows that the surgical navigation system used in chest surgeries is generally safe. Studies indicate that these systems enhance surgical precision, leading to better outcomes. One study highlighted that 3D-guided navigation in chest surgeries improved results during operations on the chest wall, suggesting the technology's reliability and effectiveness.

Additionally, research on similar systems in other surgeries has shown positive safety records. Advanced imaging during operations helps surgeons see more clearly, reducing the chances of mistakes. This technology aims to make surgeries safer and more accurate.

Overall, while specific safety data for this exact system is limited, existing information appears promising. The focus on improving surgical accuracy suggests that the system prioritizes patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Surgical Navigation System (SNS) for thoracic wall surgery is unique because it integrates real-time imaging with surgical navigation, offering surgeons enhanced precision. Traditional thoracic surgeries often rely on the surgeon's experience and static imaging, which can limit accuracy. SNS provides dynamic, intraoperative imaging, allowing surgeons to adjust in real-time during the procedure. Researchers are excited about this advancement because it could lead to more accurate surgeries, potentially reducing complications and improving patient outcomes.

What evidence suggests that this surgical navigation system is effective for thoracic wall surgery?

Research has shown that special navigation systems during chest surgeries can help doctors find and mark tumors more accurately. In this trial, participants will undergo surgery using the Surgical Navigation System (SNS), an intraoperative imaging/surgical navigation system. One study found that a thoracoscopic navigation system made it easier to locate tumors and allowed surgeons to make more precise cuts. This precision reduces the risk of cutting too much or too little, leading to fewer complications and possibly a quicker recovery. Another study introduced a system that automatically highlights important areas in surgical images, further enhancing precision. These findings suggest that navigation systems could make chest surgeries safer and more effective by helping surgeons achieve greater accuracy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

The INSPIRE trial is for adults who need surgery to remove a lesion from their chest wall. They must be able to understand and agree to the study by signing consent forms. Pregnant individuals, those with conditions making surgery unsafe, or those with metal implants that could interfere with the navigation system are not eligible.

Inclusion Criteria

Ability to provide informed consent

Must sign and be given a copy of the written informed consent form

I am scheduled for surgery to remove a chest wall lesion.

Exclusion Criteria

Pregnant, lactating, or planning to become pregnant during the period of the evaluation

My condition or tumor cannot be treated with surgery.

Participants with metallic implantation, such as ribs fixations, a pacemaker, or pedicle screws, which may affect the accuracy of CBCT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo imaging and surgery using intraoperative navigation systems for precise chest wall resection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Surgical Navigation System

Trial Overview Surgeons in this trial will use a surgical navigation system during chest wall resection procedures. The goal is to see if this technology helps them achieve more precise removal of lesions while avoiding unnecessary damage or additional surgeries.

How Is the Trial Designed?

Group I: SNS Experimental Treatment 1 Intervention

Intraoperative imaging/surgical navigation system (SNS)

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Surgical navigation systems enhance surgical precision by using advanced computer graphics and image processing to create real-time 2D or 3D models of medical images, allowing surgeons to accurately track the position of surgical instruments during procedures.

Key techniques in these systems include spatial localization, image processing, and head location tracking, which collectively improve the effectiveness and safety of surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted surgical navigation technique]. Hao, Y., Zhu, F.[2006]

In a study of 16 patients undergoing thoracoscopic discectomy, frameless stereotactic image guidance improved surgical accuracy, with registration and navigation errors measured at just 1.7 mm and 1.2 mm, respectively.

The use of image guidance did not significantly increase the overall procedure time and resulted in clinical outcomes and complication rates comparable to previous surgical experiences, suggesting enhanced safety and efficiency in complex spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided thoracoscopic spinal surgery: a merging of 2 technologies. Johnson, JP., Stokes, JK., Oskouian, RJ., et al.[2019]

The newly developed thoracoscopic surgical navigation system significantly improved the accuracy of tumor localization and resection margins, particularly for areas that are hard to see with traditional thoracoscopy, as evidenced by reduced localization errors for the medial and superior tumor margins.

Surgeons reported a substantial decrease in workload and frustration when using the navigation system, with over a 50% reduction in performance and frustration scores, indicating increased confidence during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Thoracoscopic Navigation System With Augmented Real-Time Image Guidance for Chest Wall Tumors. Lee, CY., Chan, H., Ujiie, H., et al.[2019]

A new navigation system was developed to enhance minimally invasive esophagectomy by providing real-time visualization of surgical instruments in relation to tumors and anatomical structures, potentially improving surgical precision.

The system demonstrated high accuracy with a precision of 0.95 +/- 0.78 mm in a phantom study, suggesting it could help surgeons navigate effectively to tumors and lymph nodes during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a navigation system for minimally invasive esophagectomy. Kenngott, HG., Neuhaus, J., Müller-Stich, BP., et al.[2018]

The study evaluated the precision of the SMN navigation system for drilling in the lower jaw, finding an average drilling depth of 6.23 mm with a mean distance of only 0.14 mm from the mandibular canal, indicating high accuracy in implant placement.

Out of 100 drillings, 89 were successful without perforating the canal, demonstrating the system's effectiveness, although there were 11 instances of minor perforation, highlighting the need for careful navigation during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigational precision of drilling tools preventing damage to the mandibular canal. Gaggl, A., Schultes, G., Kärcher, H.[2021]

A new computer-assisted system for minimally invasive cardiac surgery was developed, focusing on optimized port placement and real-time navigation using an optical tracker, which enhances surgical precision.

Clinical tests and experiments showed that the system achieved a fiducial registration error of just 1.08 mm, indicating high accuracy in tracking surgical instruments relative to the patient's anatomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of an integrated computer-assisted system for minimally invasive cardiac surgery. Cai, J., Luo, Z., Gu, L., et al.[2014]

In a study of 8,500 patients undergoing lumbar spine surgery, the use of computer-assisted navigation significantly reduced overall complications (24% vs. 27%) and minor complications (20% vs. 24%), as well as the need for blood transfusions (17% vs. 20%).

While navigation improved safety outcomes and shortened hospital stays, it also resulted in longer surgical times and a higher rate of wound dehiscences, indicating a trade-off between benefits and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted Navigation in Lumbar Spine Instrumented Fusions: Comparison of In-hospital and 30-Day Postoperative Complications With Nonnavigated Fusions in a National Database. Sing, D., Cummins, DD., Burch, S., et al.[2023]

In a study involving 10 pigs, researchers found that the esophagus experiences significant motion during respiration, particularly at the lower thoracic level and gastroesophageal junction, which can affect surgical navigation accuracy.

The creation of pneumoperitoneum caused notable displacement of the esophagus, highlighting the need for navigation systems to account for soft tissue deformation during thoracoabdominal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer tomographic analysis of organ motion caused by respiration and intraoperative pneumoperitoneum in a porcine model for navigated minimally invasive esophagectomy. Nickel, F., Kenngott, HG., Neuhaus, J., et al.[2019]

The newly developed surgical navigation system achieved high accuracy, with a target registration error of only 0.20 mm in a technical phantom model and 0.28 mm in ex vivo assessments, indicating it can reliably assist in delicate ear and skull base surgeries.

The system successfully integrated with endoscopic workflows during 36 procedures, allowing for accurate identification of vital anatomical structures without interfering with the surgical instruments, showcasing its potential for enhancing surgical precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and feasibility of a dedicated image guidance solution for endoscopic lateral skull base surgery. Rathgeb, C., Anschuetz, L., Schneider, D., et al.[2018]

In a multicenter study involving 311 patients and 36 surgeons, the use of the DigiPointeur® surgical navigation system (SNS) allowed for more extensive surgical procedures in 81% of cases, particularly by helping to identify and open additional anatomical structures.

Surgeons reported high satisfaction with the SNS, averaging 8.6 out of 10, and noted a significant reduction in surgical stress in 95% of cases, indicating that the SNS not only enhances surgical performance but also improves the overall experience for the surgeon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a navigation system in endonasal surgery: Impact on surgical strategy and surgeon satisfaction. A prospective multicenter study. Vicaut, E., Bertrand, B., Betton, JL., et al.[2020]

Intraoperative computer-assisted navigation, using a wireless passive marker system, enhances the precision of maxillofacial surgeries by allowing real-time tracking of instruments and displaying virtual anatomical structures during operations.

A case report of a T3N2bM0 carcinoma resection demonstrated that the Stryker Navigation Cart System effectively supported both preoperative planning and intraoperative monitoring, suggesting its potential to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral and maxillofacial surgery with computer-assisted navigation system. Kawachi, H., Kawachi, Y., Ikeda, C., et al.[2019]

The study successfully transferred navigation software to modern high-power notebook computers, demonstrating that intraoperative positional information can be effectively provided to surgeons during endoscopic endonasal surgery.

The ARTMA Virtual Patient System, when used with the Polhemus FASTRAK digitizer, achieved satisfactory navigation using various medical imaging modalities, indicating its potential for practical use in operating rooms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A full 3D-navigation system in a suitcase. Freysinger, W., Truppe, MJ., Gunkel, AR., et al.[2006]

Navigation systems, particularly 3D navigation, enhance precision in surgeries like pelvic and spine operations, leading to increased patient safety and reduced radiation exposure.

While these systems offer significant benefits, such as less invasive procedures, they come with high initial costs and require surgeons to be well-trained in both navigated and non-navigated techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does navigation still have a value in trauma surgery?] Oberthür, S., Sehmisch, S., Weiser, L., et al.[2022]

Citations

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Effectiveness of Thoracic Wall Blocks in Video-Assisted ... Here, we examine the efficacy of various thoracic fascial plane blocks vs TEA and PVB for intraoperative and postoperative analgesia for video ...

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Clinical Efficacy of Thoracoscopic Surgery with the da Vinci ... The thoracoscopic surgery with the da Vinci surgical system better reduces intraoperative and postoperative bleeding, shortens drainage and intubation duration.

3. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(18)31129-9/pdf

Novel Thoracoscopic Navigation System With Augmented ... This study showed that our thoracoscopic SNS improved tumor and surgical margin localization accuracy during minimally invasive chest wall tumor surgery with a.

4. mdpi.com mdpi.com/2076-3417/15/3/1443

Image Navigation System for Thoracoscopic Surgeries ... This study introduces a novel system employing a channel R-CNN model to automatically segment target regions in thoracoscopic images and provide precise ...

5. academic.oup.com academic.oup.com/icvts/article/34/2/201/6372815

Extended, virtual and augmented reality in thoracic surgery A systematic database search was conducted of original articles that explored the use of VR and/or augmented reality in thoracic surgery.

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Reporting of patient safety incidents in minimally invasive ... The reporting of patient safety incidents (PSIs) occurring in minimally invasive thoracic surgery (MITS) is crucial.

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Three-dimensional surgical simulation-guided navigation ... Three-dimensional surgical simulation-guided navigation in thoracic surgery: a new approach to improve results in chest wall resection and reconstruction for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425001560

Intraoperative-CT-navigated percutaneous posterior ... This study was conducted to evaluate reliability and precision of a novel intraoperative computed tomography(iCT)-based navigated procedure to minimally ...

9. mdpi.com mdpi.com/2077-0383/14/8/2729

Artificial Intelligence in Thoracic Surgery: A Review ... Background: Artificial intelligence (AI) is rapidly transforming thoracic surgery by enhancing diagnostic accuracy, surgical precision, intraoperative ...

10. ccts.amegroups.org ccts.amegroups.org/article/view/102169/html

Rethinking surgical strategies for primary chest wall sarcomas Chest wall resection and reconstruction for primary chest wall sarcomas: Analysis of survival, predictors of outcome, and long-term functional status.