Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate

NCT ID: NCT02698644

Last Updated: 2016-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-07-31

Brief Summary

Is to assess the effectiveness of hysteroscopic tubal application of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of women, which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF and in tubal sterilization.

Detailed Description

The study will be conducted according to the guidelines on human experimentation of the 1975 Declaration of Helsinki. For all patients after taking signed informed consent , transcervical hysteroscopic cannulation of the proximal one centimeter of both fallopian tubes, will be done using a 5 Fr, 42cm long, polyethylene ureteric catheter, where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected in each side.

All the surgical procedures will be performed without anesthesia, only premedication with an NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

Each patient will be under close observation for the first 24 hours postprocedure for any signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

Total abdominal hysterectomy and bilateral salpingoophorectomy will be done, second day, a week, two weeks and three weeks and four weeks after injection,. Hysterectomy samples will be sent to histopathologist to assess the degree of tubal occlusion and the extent and the severity of inflammation in the tubal wall.

Conditions

Fallopian Tube Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

isoamyl2cyanoacrylate

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Group Type: EXPERIMENTAL

Isoamyl-2-cyanoacrylate

Intervention Type: DRUG

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Interventions

Isoamyl-2-cyanoacrylate

Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter

Intervention Type: DRUG

Other Intervention Names

AMCRYLATE®

Eligibility Criteria

Inclusion Criteria

• patients planned for abdominal hysterectomy with well seen tubal ostia through hysteroscope

Exclusion Criteria

• Any patient with Upper or lower genital tract infection as evidenced by fever, lower abdominal pain or tenderness and abnormal vaginal discharge will be excluded from the study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed I Amer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed I Amer, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University maternity hospital

Locations

AIn Shams University Maternity Hospital

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed I Amer, MD

Role: CONTACT

mohamed_amer810@yahoo.com

00201001519370

Facility Contacts

Mohamed Amer, MD

Role: primary

mohamed_amer810@yahoo.com

00201001519370

Other Identifiers

ASU

Identifier Type: -

Identifier Source: org_study_id