NCT02348541

Brief Summary

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

January 19, 2015

Last Update Submit

September 2, 2021

Conditions

Hysteroscopic Adhesiolysis

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using CollaGUARD in hysteroscopic adhesiolysis: Surgeon completed questionnaire

    surgeon completed questionnaire

    following initial hysteroscopy

Secondary Outcomes (3)

  • Number of de novo adhesion and adhesion reformation

    9 weeks post initial hysteroscopy

  • Change in severity of adhesions

    9 weeks post initial hysteroscopy

  • Degradation of CollaGUARD

    2 weeks post initial hysteroscopy

Study Arms (1)

CollaGUARD

OTHER
Device: CollaGUARD

Interventions

CollaGUARDDEVICE
CollaGUARD

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
  • Willing to use additional contraception throughout study

You may not qualify if:

  • Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
  • Has suffered or currently suffers from a gynaecological malignancy
  • Has undergone a previous hysteroscopic surgery (such as removal of fibroids)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

Study Officials

  • David Prior, PhD

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 28, 2015

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

NL(2)