E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients that undergo surgery that involves the ovaries
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033137 |
E.1.2 | Term | Ovarian cystectomy |
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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 |
The objective of the study is to evaluate the safety and initial efficacy of the anti-adhesion kit (AA) AdhexilTM for the prevention and/or reduction of prospective adhesions in female patients who are undergoing a surgical procedure involving the ovaries. |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives for this study. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Female patients aged 18-45 years at screening 2.Patients undergoing elective laparoscopic surgery due to known or suspected bilateral ovarian disease 3.Patients must be willing to participate in the study, and provide written informed consent 4.Patient available and willing to undertake study visits and procedures 5.Patients of child-bearing potential must be using a medically acceptable method of birth control throughout the study. 6.Presence of both ovaries and both intact fallopian tubes.
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E.4 | Principal exclusion criteria |
1.Pregnant (including ectopic pregnancy) or breastfeeding patients 2.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation 3.Patients whose 1LL procedure would involve surgical sterilization 4.Patients whose 1LL procedure would involve hysterectomy 5.Patients with a documented diagnosis of cancer 6.Patients with a lymphatic, hematologic or coagulation disorder 7.Known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™ 8.Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges 9.Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants. 10.Patients who have participated in another clinical study within 30 days of enrolment. 11.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study 12.Patients with American Society of Anesthesiologists class > I
Intra-Operative Exclusion Criteria 1.Failure to lyse any of the existing ovarian adhesions 2.Absence of one or both ovaries 3.Absence of one or both Fallopian tubes 4.Presence of active infection. 5.Presence of malignancy 6.Use of heparin-containing irrigants 7.Use of other adjuvants for the purpose of reducing adhesions, including INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex, corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents. 8.Requirement to perform enterotomy and/or cystotomy and/or urostomy and/or hysterectomy 9.Patients who underwent a peritoneal grafting procedure 10.Patients in whom a procedure required conversion to laparotomy 11.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or immediately adjacent structures 12.Use of gasless laparoscopy 13.Performance of non-gynecologic surgical procedure (cholecystectomy) 14.Investigator’s opinion that a second look is not in the best interest of the patient
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the incidence of ovaries with adhesions. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
different indication for an approved product |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 |
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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 | Yes |
E.8.2.3.1 | Comparator description |
Untreated ovary of the same patient (only one side will be treated) |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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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Each patient will be treated with Adhexil and will be followed for safety and efficacy evaluations for a period of 6(+/-4) weeks after surgery (with exceptional cases at not later than 14 weeks after 1LL), and a 30 day follow up for adverse events. End of study is defined as the time of database lock, and will occur when the 30 day follow up period will be over for the last patient. |
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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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |