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NCT03569943: ROBOTOL
Robot Based Tympanic Tube Placement
NA trial testing Robot Based Transtympanic drain placement in Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion. Withdrawn.
1 January 2020
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Start date | 3 January 2019 |
| Primary completion | 1 January 2020 |
| Estimated completion | 28 February 2020 |
Drugs / interventions tested
- Robot Based Transtympanic drain placement
Conditions studied
- Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion — all drugs for Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with Patient Operated on From a Vestibular Schwannoma With a Middle Ear Exclusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Middle ear surgery is performed in a deep workspace through a narrow approach to the tympanic cavity, either by the external auditory canal, or by drilling the temporal bone. It uses thin and long instruments as a delicate and precise gesture on the ossicular chain or manipulation of very light prostheses is necessary. The results of middle ear procedures relies upon the surgeon experience and his gesture accuracy. For this reason, a robot-based device designed to assist the surgeon during middle ear procedure has been build. The goal of the present protocol is to evaluate the robot in a simple procedure to ensure its safety before using the device in more complex cases. The precision of the robot during transtympanic tube placement will be evaluated. The following benefits are expected: * Significantly reduced risk of transtympanic tube on the other side of the eardrum. * Positioning of the transtympanic tube in the desired tympanic quadrant * Reduces the size of the entry point to prevent tearing * Reduced risk of injury to the external auditory canal Once the safety of use of the robot is demonstrated in this protocol, the goal will be to evaluate it later in more complex surgical gestures in other protocols. The future application of the robot will be the placement of middle ear implant prosthesis in the context of the surgery for cholesteatoma, otosclerosis or insertion of cochlear implants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03569943
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03569943 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 19 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03569943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing