E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014778 |
E.1.2 | Term | Endometriosis |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate feasibility as to which enhanced imaging technique has the best sensitivity in detecting peritoneal endometriosis, compared to conventional white light laparoscopy. |
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E.2.2 | Secondary objectives of the trial |
- Specificity - Negative and positive predictive value - Direct costs - Usability - Descriptive analysis of the by endometriosis affected ovaries and intestines. - Occurrence of (serious) adverse events / patient safety - Time of the procedure / operation time (minutes) - Blood loss - Difference in detection (staining) between superficial (peritoneal) endometriosis and deep endometriosis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Oral and written informed consent • Age 18 years and older • Premenopausal women • Elective laparoscopic treatment of endometriosis lesions by CO 2 laser/ bipolar diathermy or surgical excision. • Presence of endometriosis (ASRM III-IV) confirmed by previous laparoscopy or likely to be present based on TVUS or MRI, including uni- or bilateral ovarian endometrioma. • Regular preoperative work-up
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E.4 | Principal exclusion criteria |
• Women who are legally or mentally incapable or unable to give informed consent • Age younger than 18 years • ASA (American Society of Anaesthesiologists) score higher than 3 • Woman who have had major open abdominal surgery • Pregnancy • Malignancy • Iodine allergy • Hypersensitivity reaction to prior usage of indocyanin green injection • Hyperthyroidism or autonomous thyroid adenoma • Chronic kidney failure (eGFR<55) • Chronic liver failure (ASAT, ALAT, AF and yGT > two times the max normal value)
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the sensitivity of Narrow Band Imaging, near-infrared imaging with ICG and 3D-laparoscopy compared to conventional white light laparoscopic imaging. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After pathological examination of all biopsies |
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E.5.2 | Secondary end point(s) |
- Specificity - Negative and positive predictive value - Descriptive analysis of the by endometriosis affected ovaries and intestines. - Descriptive analysis of the difference in detection between superficial (peritoneal) endometriosis and deep endometriosis. - Descriptive and quantitative analysis of the occurrence of (serious) adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After pathological examination of all biopsies |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
prospective, single-center, pilot (feasibility) trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends after the twenthieth patient has been treated. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |