E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adhesions in gynecology surgery. Surgeries involved will be ovarian cystectomy, endometriosis, inflammation, adhesiolysis
Ovarian adhesion MedDRA 10067156 Tubal rupture MedDRA 10067553 |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014778 |
E.1.2 | Term | Endometriosis |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004433 |
E.1.2 | Term | Benign ovarian tumour |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053865 |
E.1.2 | Term | Benign fallopian tube neoplasm |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050697 |
E.1.2 | Term | Fallopian tube cyst |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061855 |
E.1.2 | Term | Fallopian tube neoplasm |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048991 |
E.1.2 | Term | Ovarian adenoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033132 |
E.1.2 | Term | Ovarian cyst |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033136 |
E.1.2 | Term | Ovarian cyst ruptured |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064257 |
E.1.2 | Term | Ovarian fibroma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033236 |
E.1.2 | Term | Ovarian germ cell teratoma benign |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061535 |
E.1.2 | Term | Ovarian neoplasm |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052456 |
E.1.2 | Term | Parovarian cyst |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036049 |
E.1.2 | Term | Polycystic ovaries |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033139 |
E.1.2 | Term | Ovarian disorder |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033263 |
E.1.2 | Term | Ovarian haematoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065741 |
E.1.2 | Term | Ovarian haemorrhage |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058823 |
E.1.2 | Term | Ovarian mass |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033277 |
E.1.2 | Term | Ovarian prolapse |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033279 |
E.1.2 | Term | Ovarian rupture |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046988 |
E.1.2 | Term | Varicocele ovarian |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052094 |
E.1.2 | Term | Fallopian tube disorder |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065789 |
E.1.2 | Term | Fallopian tube obstruction |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065790 |
E.1.2 | Term | Fallopian tube perforation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065791 |
E.1.2 | Term | Fallopian tube stenosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050468 |
E.1.2 | Term | Haematosalpinx |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061071 |
E.1.2 | Term | Congenital ovarian anomaly |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061062 |
E.1.2 | Term | Congenital fallopian tube anomaly |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067156 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060781 |
E.1.2 | Term | Haemorrhagic ovarian cyst |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 11.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067553 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033157 |
E.1.2 | Term | Ovarian enlargement |
|
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 this study is to evaluate the safety and efficacy of ADHEXIL in preventing and/or reducing post-operative adhesions in patients undergoing gynecology surgery. |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives for this trial. |
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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 scheduled for elective laparoscopic gynecology surgery involving at least one adnexa, due to ovarian cysts and/or endometriosis and/or prior inflammation and/or existing adhesions. 3. Patients must be willing to participate in the study, and provide written informed consent. 4. Patients must be 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 until the date of the 2LL. 6. Patient must have at least one adnexa (ovary and its adjacent tube
Intra-Operative Inclusion Criteria 1. Patient must have at least one adnexa (ovary and its adjacent tube) 2. Raw surface involving at least 1cm2 of adnexa surface prior to suturing/cautery.
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E.4 | Principal exclusion criteria |
1. Pregnant (including current ectopic pregnancy) or breastfeeding patient. 2. Patients whose 1LL procedure would involve surgical sterilization. 3. Patients whose 1LL procedure would involve hysterectomy. 4. Patients with a lymphatic, hematologic or coagulation disorder. 5. Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of ADHEXIL™. 6. Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges and are clinically significant, as classified by the investigator. 7. Patients who are immunocompromised, possess autoimmune disorders. 8. Patients who are routinely taking anticoagulants. 9. Patients who have participated in another clinical study within 30 days of enrolment. 10. Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study. 11. Patients with American Society of Anesthesiologists class > 2 (see appendix B for classification). 12. Patients with a known or suspected hypersensitivity to Indigo Carmine 13. Patients diagnosed with adnexal cancer
Intra-Operative Exclusion Criteria 1. Presence of active infection. 2. Use of heparin-containing irrigants. 3. Use of other agents for the purpose of reducing adhesions, including corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents. 4. Use of INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex or any other adhesion reduction agent. 5. Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation. 6. Patients in whom a procedure required conversion to laparotomy. 7. 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 tubes or immediately adjacent structures. 8. Use of gasless laparoscopy. 9. Performance of non-gynecologic surgical procedure (e.g. cholecystectomy). 10. 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 AFS score of adhesion at the target adnexa at 2LL. |
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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) | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |