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| Name | Class |
|---|---|
| Mauna Kea Technologies | INDUSTRY |
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This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).
Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.
The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
This study involves several innovations including :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| confocal laser endomicroscopy | Experimental | confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| confocal laser endomicroscopy | Device | probe-based and needle-based confocal laser endomicroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with adverse events, their type and severity | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| The ease of manipulation of the robotized probe (grade 1 to 5) | during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| the quality of real time communication between the pathologist lab and the OR (grade 1 to 5) | during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication | 8 months |
| number of interpretable images per organ, per contrast agent and per pathology |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brice GAYET, MD | Mutualiste Montsouris Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mutualiste Montsouris Institute | Paris | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30232616 | Derived | Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19. |
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| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012004 | Rectal Neoplasms |
| D008113 | Liver Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D004379 | Duodenal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D004701 | Endocrine Gland Neoplasms |
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each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications. |
| 8 months |
| D010049 |
| Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008107 | Liver Diseases |
| D010182 | Pancreatic Diseases |
| D004378 | Duodenal Diseases |