Revision Surgery for Cochlear Implant Tissue Growth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age < 18, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance cochlear implant function by examining scar tissue growth around the implant. Scar tissue can impact the implant's ability to stimulate the auditory nerve, and researchers seek to determine if adjusting the implant's programming can help. The trial collects data from individuals undergoing cochlear implant revision surgery, enabling surgeons to directly assess scar tissue. Those with cochlear implants undergoing revision surgery at Vanderbilt University Medical Center may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to advancements in cochlear implant technology.

Will I have to stop taking my current medications?

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

What prior data suggests that this revision surgery for cochlear implant tissue growth is safe?

Research has shown that cochlear implant revision surgery is generally safe. In one study, more than 95% of the devices functioned after five years, and over 90% remained operational after fifteen years. Another study found that replacing a cochlear implant can maintain or even improve hearing and speech. This indicates that the procedure is not only safe but also effective for many patients.

However, some complications can occur. A report noted a major complication rate of 6.6%, primarily due to device failures. These incidents are relatively rare but should be considered.

Overall, cochlear implant revision surgery is well-tolerated and beneficial for many, with most patients experiencing good outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cochlear implant complications, which often involve managing symptoms or using medications to reduce tissue growth, cochlear implant revision surgery offers a direct approach to address the issue. This surgery specifically targets the excess tissue growth around the implant, which can impair hearing function. Researchers are excited about this method because it not only aims to restore the implant's effectiveness but also provides a long-term solution to a problem that current treatments only manage temporarily. By directly removing or modifying the problematic tissue, this surgical technique has the potential to significantly improve patients' quality of life by enhancing their hearing capabilities.

What evidence suggests that cochlear implant revision surgery is effective for addressing tissue growth?

Studies have shown that undergoing cochlear implant surgery again can improve hearing when the first implant encounters problems. Research indicates that updated surgical methods during follow-up surgeries lead to better results than traditional methods. Many patients who undergo revision surgery notice improvements, with few major complications. Over the years, evidence suggests that these surgeries effectively address issues like device failures or incorrect placement, enhancing implant performance and, consequently, the user's hearing. ^{2 3 4 5 6}

Who Is on the Research Team?

Robert Labadie, MD,PhD

Principal Investigator

Vanderbilt University Medical Center

Jack Noble, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adults over the age of 18 who are already using cochlear implants and need to have revision surgery. It's not open to anyone under 18 or those who aren't scheduled for this type of surgery.

Inclusion Criteria

I am 18 or older and need another cochlear implant surgery.

Exclusion Criteria

I am under 18 years old or I am not having repeat cochlear implant surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Observation

Participants undergo cochlear implant revision surgery where the presence of scar tissue growth is evaluated by visual confirmation by the surgeon

Intraoperative

Data Collection and Analysis

Data necessary to validate computational model predictions of tissue growth is collected and analyzed

4-8 weeks

Follow-up

Participants are monitored for any post-surgical complications and the effectiveness of the computational model predictions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• cochlear implant revision surgery

Trial Overview The study tests a new way to use CT images and device measurements to simulate how cochlear implants work in the ear, especially when scar tissue forms around them. The goal is to see if these simulations can help improve implant programming by predicting tissue growth.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

The single observational cohort

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10330224/

Cochlear implant revisions over three decades of experience The objective of this study was to analyze the rates, indications, and audiologic outcomes for cochlear implant revision (CIR) over three decades of experience.

2. mdpi.com mdpi.com/2075-4418/15/2/186

Determinants of Success in Revision Cochlear Implant ... Modified surgical techniques were employed in 46.81% of cases and were significantly associated with better outcomes than standard techniques (p = 0.012).

3. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924001868

Cochlear reimplantation outcomes over 20 years As indicated in Table 4, a total of 20 patients underwent revision surgery with a major complication rate of 1.8 %.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932275/

Long-Term Outcomes Following Cochlear Implantation In this study, of 925 CI patients, 43 underwent revision surgery (4.6%). The mean total follow-up duration was 7.1 years. Lane et al. reviewed ...

5. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/ohn.805

Revision Cochlear Implantation With Device Manufacturer ... This retrospective study showed that RCI involving MC is safe and beneficial. Although RCI mc+ patients exhibited distinct clinical characteristics, MC did not ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059107/

Evaluating Reasons for Revision Surgery and Device ... In the survival analysis, the overall cumulative survival and device survival rates were more than 95% in 5 years and more than 90% in 15 years.